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ARTICLE CONTENTS

* ABSTRACT
* INTRODUCTION
* METHODS
* RESULTS
* DISCUSSION
* CONCLUSION
* ACKNOWLEDGMENT
* FUNDING
* CONFLICT OF INTEREST STATEMENT
* DATA AVAILABILITY
* CLINICAL TRIAL REGISTRATION
* INSTITUTIONAL REVIEW BOARD (HUMAN SUBJECTS)
* INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)
* INSTITUTIONAL CLEARANCE
* INDIVIDUAL AUTHOR CONTRIBUTION STATEMENT
* REFERENCES
* Author notes

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Journal Article

HYPOGLOSSAL NERVE STIMULATOR IN THE ACTIVE DUTY POPULATION: MILITARY READINESS
AND SATISFACTION

Matthew T Ryan, MD,
Matthew T Ryan, MD
Department of Otolaryngology Head and Neck Surgery, Walter Reed National
Military Medical Center
, Bethesda, MD 20889,
USA
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Michael Coulter, MD,
Michael Coulter, MD
Department of Otolaryngology Head and Neck Surgery, Naval Medical Center
, San Diego, CA 92134,
USA
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Jeeho Kim, MD,
Jeeho Kim, MD
N9 Medical, Navy Operation Support Center, Washington DC
, Joint Base Andrews, MD 20762,
USA
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Michael Noller, MD,
Michael Noller, MD
Department of Otolaryngology Head and Neck Surgery, Walter Reed National
Military Medical Center
, Bethesda, MD 20889,
USA
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Douglas Mack,
Douglas Mack
Department of Otolaryngology Head and Neck Surgery, Brook Army Medical Center
, San Antonio, TX 78234,
USA
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Elizabeth Huuki,
Elizabeth Huuki
School of Medicine, Uniformed Services University of the Health Sciences
, Bethesda, MD 20814,
USA
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Charles A Riley, MD,
Charles A Riley, MD
Department of Otolaryngology Head and Neck Surgery, Walter Reed National
Military Medical Center
, Bethesda, MD 20889,
USA
Department of Surgery, Uniformed Services University of the Health Sciences
, Bethesda, MD 20814,
USA
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Anthony M Tolisano, MD
Anthony M Tolisano, MD
Department of Otolaryngology Head and Neck Surgery, Walter Reed National
Military Medical Center
, Bethesda, MD 20889,
USA
Department of Surgery, Uniformed Services University of the Health Sciences
, Bethesda, MD 20814,
USA
https://orcid.org/0000-0001-8240-8330
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This research was presented at Combined Otolaryngology Spring Meeting in Dallas,
TX, as a poster on April 27, 2022.

The views expressed in this material are those of the authors and do not reflect
the official policy or position of the U.S. Government, the DoD, or the
Department of the Army.

Author Notes
Military Medicine, usad069, https://doi.org/10.1093/milmed/usad069
Published:
09 March 2023
Article history
Received:
18 October 2022
Revision received:
13 January 2023
Editorial decision:
19 February 2023
Accepted:
24 February 2023
Corrected and typeset:
09 March 2023
Published:
09 March 2023

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CITE

Matthew T Ryan, Michael Coulter, Jeeho Kim, Michael Noller, Douglas Mack,
Elizabeth Huuki, Charles A Riley, Anthony M Tolisano, Hypoglossal Nerve
Stimulator in the Active Duty Population: Military Readiness and
Satisfaction, Military Medicine, 2023;, usad069,
https://doi.org/10.1093/milmed/usad069

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ABSTRACT

Introduction

Because inadequate sleep impairs mission performance, the U.S. Army regards
sleep as a core pillar of soldier readiness. There is an increasing incidence of
obstructive sleep apnea (OSA) among active duty (AD) service members, which is a
disqualifying condition for initial enlistment. Moreover, a new diagnosis of OSA
in the AD population often prompts a medical evaluation board, and if
symptomatic OSA proves refractory to treatment, this may result in medical
retirement. Hypoglossal nerve stimulator implantation (HNSI) is a newer
implantable treatment option, which requires minimal ancillary equipment to
function and may provide a useful treatment modality to support AD service
members while maintaining readiness in appropriate candidates. Because of a
perception among AD service members that HNSI results in mandatory medical
discharge, we aimed to evaluate the impact of HNSI on military career
progression, maintenance of deployment readiness, and patient satisfaction.

Methods

The Department of Research Programs at the Walter Reed National Military Medical
Center provided institutional review board approval for this project. This is a
retrospective, observational study and telephonic survey of AD HNSI recipients.
Military service information, demographics, surgical data, and postoperative
sleep study results were collected from each patient.Additional survey questions
assessed each service member’s experience with the device.

Results

Fifteen AD service members who underwent HNSI between 2016 and 2021 were
identified. Thirteen subjects completed the survey. The mean age was 44.8 years
(range 33-61), and all were men. Six subjects (46%) were officers. All subjects
maintained AD status following HNSI yielding 14.5 person-years of continued AD
service with the implant. One subject underwent formal assessment for medical
retention. One subject transferred from a combat role to a support role. Six
subjects have since voluntarily separated from AD service following HNSI. These
subjects spent an average of 360 (37-1,039) days on AD service. Seven subjects
currently remain on AD and have served for an average of 441 (243-882) days. Two
subjects deployed following HNSI. Two subjects felt that HSNI negatively
affected their career. Ten subjects would recommend HSNI to other AD personnel.
Following HNSI, of the eight subjects with postoperative sleep study data, five
achieved surgical success defined as >50% reduction of apnea–hypopnea index and
absolute apnea–hypopnea index value of <20.

Conclusions

Hypoglossal nerve stimulator implantation for AD service members offers an
effective treatment modality for OSA, which generally allows for the ability to
maintain AD status, however: The impact on deployment readiness should be
seriously considered and tailored to each service member based on their unique
duties before implantation. Seventy-seven percent of HNSI patients would
recommend it to other AD service members suffering from OSA.

Topic:
* client satisfaction
* institutional review board
* obstructive sleep apnea
* demography
* military hospitals
* military personnel
* perception
* polysomnography
* surgical procedures, operative
* diagnosis
* sleep
* medical devices
* apnea-hypopnea index procedure
* soldiers
* army
* implants
* treatment effectiveness
* upper airway hypoglossal nerve stimulation device

Issue Section:
Brief Report

INTRODUCTION

Because inadequate sleep impairs mission performance, the U.S. Army regards
sleep as a core pillar of soldier readiness. As a result of increased screening
and awareness, the incidence of obstructive sleep apnea (OSA) among active duty
(AD) service members has risen from 11 per 10,000 in 2005 to 333 per 10,000 in
2019.1 Deployments overseas to directly support or fight in military operations
increase the likelihood of developing OSA which itself exacerbates PTSD.2 In a
vicious cycle, PTSD reduces compliance for positive airway pressure (PAP)
treatment.3,4

Currently, PAP is the gold standard treatment for OSA. Unfortunately, because
PAP treatment in austere environments is difficult, the U.S. Army considers OSA
to be a disqualifying condition for initial enlistment. Moreover, a new
diagnosis of OSA in the AD population often prompts a medical evaluation board
if OSA cannot be corrected with weight loss, PAP, surgery, or an oral
appliance.5 Hypoglossal nerve stimulator implantation (HNSI) is a newer
treatment option that activates the hypoglossal nerve during inspiration while
asleep to protrude the tongue and relieve upper airway obstruction at the
retrolingual and retropalatal levels. The device consists of a stimulator lead
placed onto the hypoglossal nerve through a neck incision and a pulse generator
implanted in a subcutaneous pocket overlying the pectoralis major with a sense
lead placed in the intercostal space (Fig. 1).6 It decreases the apnea–hypopnea
index (AHI)—a measure of the number of times per hour an individual has abnormal
respiratory events—by 68% 1 year after implantation, reduces daytime sleepiness,
and improves quality of life.7 HNSI requires minimal ancillary equipment to
function (in contradistinction to PAP) and may provide a useful treatment
modality to support military readiness in appropriate candidates.

FIGURE 1.
Open in new tabDownload slide

Depiction of the standard placement of the hypoglossal nerve stimulator
implantation generator and lead.

Nevertheless, AD service members often forego HNSI because of concerns that an
implant itself may result in military disqualification, a finding mirrored
previously for AD cochlear implantation recipients.8 Given the relatively new
technology and limited experience among AD service members, there is no explicit
ban codified within the military regulations. However, similar implantable
devices such as cochlear implants and pacemakers are considered disqualifying
from enlistment into military service.5,9 What remains to be seen is how
receiving an implant as a current AD service member affects retention,
deployment, and career progression. This creates a potential barrier to care for
patients who might otherwise qualify for and benefit from HNSI. The objectives
of this study, therefore, were to explore the impact of the HNSI on military
career progression, retention, and the ability to deploy.

METHODS

Study participants consisted of HNSI recipients who were on AD at the time of
surgery and who were willing to participate in a telephonic survey. Candidacy
for HNSI was determined utilizing FDA indications at the time surgery was
performed: Age >18 years, failure of PAP therapy, AHI between 15 and 65
events/hour, central apnea index <25% of the AHI, no complete concentric
collapse on drug-induced sleep endoscopy, and a body mass index (BMI) <32 kg/m2.
All implanted participants met these FDA indications. Investigators identified
AD HNSI recipients from surgical records at four military hospitals.

Investigators contacted subjects telephonically and obtained consent. Survey
questions were designed to capture the implanted patients’ experience within the
context of their role as an AD service member. Military service information
consisting of military occupation, branch of service, and rank at the time of
surgery was collected from each patient. Figure 2 contains the additional survey
questions asked regarding each service member’s experience with the device.
Basic demographics, including age at the time of implant, sex, and race, were
recorded. Pre- and postoperative polysomnogram data were collected for each
participant (Table I). Postoperative AHI was collected from the most recent
sleep evaluation. Surgical data, including complications, were recorded. Data
were entered into a de-identified Microsoft Excel (Redmond, WA) spreadsheet.
Descriptive statistics were performed to evaluate demographic characteristics,
preoperative polysomnogram data, and responses to the survey questions. AD
person-years were calculated as the cumulative sum of time spent on AD since
HNSI.

FIGURE 2.
Open in new tabDownload slide

Survey questionnaire given to all study participants.

TABLE I.

Patient Demographics and Military Service Information

. n (%) . Total participants13Mean age45.4 ± 7.6 (range 33-61)Mean AHI
(Preoperative, n = 13)35.8Mean AHI (Postoperative, n = 8)13.15BMI (mean)28.4
(range 23-32)SexMale13 (100)Female0 (0)MOSCombat1 (8)Support9 (69)Unknown3
(23)Rank/rateSenior officer6 (46)Junior officer0 (0)Senior enlisted6 (46)Junior
enlisted1 (8)

Abbreviations: AHI, apnea–hypopnea index; BMI, body mass index; Junior enlisted,
E1-E4; Junior officer, O-1 to O-3; MOS: military occupation; Senior enlisted:
E5- E9—also known as non-commissioned officers; Senior officer: O-4 and above.

Open in new tab
TABLE I.

Patient Demographics and Military Service Information

Open in new tab

RESULTS

Between 2016 and 2021, 15 AD service members underwent HNSI at the four highest
volume HNSI centers; Brooke Army Medical Center (3 patients), Naval Medical
Center Portsmouth (3 patients), Naval Medical Center San Diego (4 patients), and
Walter Reed National Military Medical Center (5 patients). Of these, two Walter
Reed subjects were unable to be contacted and therefore excluded from the survey
portion of the study. One of these subjects was deployed at the time of the
study and was included for deployment-specific results.

DEMOGRAPHICS

All study participants were men between the ages of 33 and 61 years (mean:
45.4). Six (46%) were officers. Eight subjects reported that their diagnosis of
OSA was related to their military service. Stress, PTSD, depression, long work
hours, work–life imbalance, and frequent job-related sleep disturbances were
noted as the service-related causes. One individual reported a knee injury
sustained during military service that resulted in weight gain as a predisposing
condition for OSA. The remaining five individuals denied or were ambivalent as
to whether their military service was related to the diagnosis of OSA.

Before HNSI, all subjects (n = 13, 100%) had been treated with continuous
positive airway pressure. In addition, subjects reported treatment with oral
appliances (n = 5, 38%), bilevel positive airway pressure (n = 3, 23%),
uvulopalatopharyngoplasty (n = 2, 15%), and nasal strips (n = 1, 8%). At the
time of HNSI, subjects had an average AHI of 35.8 events/hour and a BMI of
28.4 kg/m2.

CAREER IMPACT

All 13 subjects maintained AD status following HNSI surgery, yielding 14.5
person-years of continued AD service. Of these, seven (54%) have since
voluntarily separated from AD service, averaging 441 days (range 243-882 days)
of AD service from the time of HNSI surgery to retirement. None of these service
members reported HNSI as a causal factor for separation. Two subjects (15%)
reported a negative effect on their career progression and promotion because of
HNSI surgery. Eighty-five percent of service members reported neutral (n = 4) to
no (n = 7) negative impact on their career because of HNSI surgery.

Five (38%) service members reported negative impact on readiness after HNSI. One
subject was formally assessed for retention eligibility for symptomatic OSA
after HNSI with resultant deployment limitations. Two others reported deployment
limitations because of the presence of the device itself. One subject reported
an inability to continue in his current combat role and was required to switch
to a non-combat position. In contrast, one subject reported improved medical
readiness because of improved sleep and activity level after HNSI. Following
HNSI surgery, two subjects have since deployed (Table II).

TABLE II.

Reported Impact on Military Readiness and Career Progression/Promotion and
Recommendation to Other Active Duty Service Members. Select Descriptive
Explanation for Survey Answers are Noted

Readiness affected, n (%) . Impact on career progression/promotion, n (%)
. Would recommend HNSI to other AD service members, n (%) . Yes . Neutral . No
. Yes . Neutral . No . Yes . Neutral . No . 5 (38)1 (8)7 (54)2 (15)4 (31)7
(54)10 (77)2 (15)1 (8)

Abbreviations: AD, active duty; HNSI, hypoglossal nerve stimulator implantation.

Open in new tab
TABLE II.

Reported Impact on Military Readiness and Career Progression/Promotion and
Recommendation to Other Active Duty Service Members. Select Descriptive
Explanation for Survey Answers are Noted

Abbreviations: AD, active duty; HNSI, hypoglossal nerve stimulator implantation.

Open in new tab

MANAGEMENT OF OSA

Following HNSI, average AHI decreased to 13.15 events/hour. Of the eight
subjects with postoperative AHI data, five achieved surgical success defined as
an AHI reduction >50% and absolute value of <20. Eleven subjects (85%) denied
postoperative complications, whereas two reported pain at surgical sites or
hypertrophic scars. Long-term problems because of HNSI were identified as
pruritic scars (n = 1) and discomfort from electric stimulation (n = 2). One
subject denied long-term complications but reported that he stopped using the
stimulator because of perceived ineffectiveness. Ten subjects (77%) would
recommend HNSI to other AD service members. Two were ambivalent and one would
not recommend the surgery (Table II).

DISCUSSION

We have identified three main findings on the career and readiness impact of
HNSI on AD service members. First, 85% of HNSI recipients do not report a
negative impact on their career advancement. Second, HNSI can significantly
impact deployment readiness for certain military occupations. Third, HNSI
recipients report a high level of satisfaction and 77% would recommend HNSI for
other AD service members with OSA.

In contrast to the perception among AD service members that the HNSI would be
tantamount to disqualification, this study identified that involuntary
separation because of HNSI has not occurred in any patients. The medical
evaluation board process, a generally undesired process for AD service members
because of the concern for involuntary separation, occurred only one time out of
the 13 implanted individuals. Overall deployment readiness had the largest
impact on career progression with 15% of patient’s reporting a negative impact
on their career advancement because of these limitations. This compares
similarly to a study in which AD service members underwent cochlear
implantation: 25% required a medical evaluation board, 80% maintained AD status,
and 11.8% felt that their career was negatively impacted.8

It is common practice for service members to undergo medical evaluations and
treatments for conditions that are potentially disqualifying at the end of their
career. In agreement with prior studies which note that 48.1% of all incident
cases of OSA among AD service members were diagnosed in the last year of
service,3 our study indicates that AD personnel are being evaluated for HNSI at
the end of their careers. Although many implanted service members did not feel
that their career progression was negatively impacted, 54% of these patients
have since voluntarily separated from the military. The average AD service
member who undergoes HNSI spends less than 1.5 years AD after being implanted.
As such, a significant limitation of this study is that it is unclear if these
AD service member’s careers would have been more impacted if they were not
nearing voluntary separation.

HNSI recipients are concerned with the impact the implant will have on their
ability to perform their assigned duties and to deploy to austere environments.
HNSI does appear to limit a minority of subjects for certain combat roles. This
limitation is specific to each individual’s role but includes concerns with body
armor fitting, loss of ability to perform certain tasks (e.g., parachuting),
lack of specialty care and equipment, and concern over interference of the
device with electronic warfare weapons. Deployment limitations occurred in 15%
of cochlear implant recipients versus 38% of HNSI recipients. Although this
difference is likely because of several factors, the HNSI generator’s location
in the chest poses greater challenges for right-handed shooters and is more
obtrusive in regard to personal protective equipment fitting than a cochlear
implant. Some approaches to minimize these issues would be adjustments to the
standard implantation techniques, such as altering the location of the pulse
generator and altering the surgical technique to position the electrodes more
optimally. These considerations would be unique to each service member and their
specific job requirements, duty hazards, handedness, and protective equipment.

Seventy-seven percent of HNSI recipients are satisfied with the device and
recommend it to other AD service members who are candidates. AD service members
treated for OSA with HNSI have adequate results with an improvement of AHI from
35.8 to 13.5 events per hour or a decrease of 62%. This value mirrors prior
studies that demonstrate AHI improvement of 55-68%.10–12 62.5% achieved surgical
success, which approaches published success rates of 63-75%.10–12 Twenty-three
percent of our study participants reported mild postoperative issues with no
significant adverse advents. This is comparable to published data reporting a
postoperative minor adverse event rate of 31%.9

Adequate treatment of OSA while minimizing the impact on readiness among AD
service members is critical because of the increasing incidence of OSA which has
been most pronounced since active combat operations began with the Gulf War.
Theories as to why there has been an increase in sleep disorder diagnoses, and
in particular OSA, over that time period include marked increase in physical and
mental combat injuries and resultant poly-pharmacy, chronic sleep fragmentation,
and increased awareness and testing for sleep disorders.13 Deployments and blunt
trauma are significant risk factors for development of sleep disorder,
particularly insomnia and OSA.13,14 Consequently, approximately 9% of all AD
personnel carry a profile for a sleep-related condition and among recently
deployed personnel who suffered a traumatic brain injury that the number rises
to 34%.15,16 Not surprisingly, 62% of our participants felt that their OSA was
directly related to their military service.

OSA can also limit AD service members from recovering from other service-related
injuries, which further highlights the importance of adequately managing this
condition. OSA predicts higher PTSD symptoms across those being treated for
PTSD.17 Sleep disorders lead to decreased quality of life and higher rates of
mental illness and depression among AD personnel.3,4,18 Additionally, any sleep
disorder diagnosis has been shown to have up to a two-fold risk of suicidal
ideation and attempts.19–22

There are several limitations to this study. Our study included only male
participants. Although existing data indicate that AD women are diagnosed with
OSA at a lower rate than men are, they are more likely to have other comorbid
conditions and suffer from PTSD, depression, and anxiety.23 Additionally,
although officers account for only 18% of the military force,24 they accounted
for 46% of the subjects who underwent HNSI. This discrepancy may be the result
of longer career and older average age among officers when compared to enlisted
personnel. However, it is also possible that differences in education level may
have influenced the HNSI referral process and decision to pursue surgery.
Finally, this study was limited because of the small number of AD HNSI
recipients, making statistical analysis comparing our study population to other
populations, as well as analyzing differences within our population with respect
to age, sex, and military rank, impossible. Future research should continue to
study this population to evaluate objective improvements in sleep.

CONCLUSION

HNSI for AD service members offers an effective treatment modality for OSA which
generally allows for the ability to maintain AD status; however, the impact on
deployment readiness should be seriously considered and tailored to each service
member based on their unique duties before implantation. Over 75% of implant
recipients are happy with their decision and would recommend it to other AD
service members suffering from OSA.

ACKNOWLEDGMENT

None declared.

FUNDING

None declared.

CONFLICT OF INTEREST STATEMENT

None declared.

DATA AVAILABILITY

The data that support the findings of this study are available on request from
the corresponding author.

CLINICAL TRIAL REGISTRATION

Not applicable.

INSTITUTIONAL REVIEW BOARD (HUMAN SUBJECTS)

The Department of Research Programs at the Walter Reed National Military Medical
Center provided institutional review board approval for this project. IRB and
REFERENCE no. WRNMMC-EDO-2021-0749, 938221.

INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE (IACUC)

Not applicable.

INSTITUTIONAL CLEARANCE

Institutional clearance approved.

INDIVIDUAL AUTHOR CONTRIBUTION STATEMENT

All authors were involved in study design and data collection. M.R. guided the
project and drafted the original manuscript. M.C., J.K., M.N., and E.H. were
integral in designing the questionnaire and collected the data as well as
drafted and edited portions of the manuscript. J.K. and E.H. additionally
provided background research and literature review. C.A.R. and A.M.T. were the
senior authors on the project providing guidance on study design and clinical
expertise to develop the questionnaire. They edited and provided input and
guidance toward writing of the manuscript. All authors read and approved the
final manuscript.

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AUTHOR NOTES

This research was presented at Combined Otolaryngology Spring Meeting in Dallas,
TX, as a poster on April 27, 2022.

The views expressed in this material are those of the authors and do not reflect
the official policy or position of the U.S. Government, the DoD, or the
Department of the Army.

Published by Oxford University Press on behalf of the Association of Military
Surgeons of the United States 2023. This work is written by (a) US Government
employee(s) and is in the public domain in the US.
This work is written by (a) US Government employee(s) and is in the public
domain in the US.

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