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In reference to Impact of Insomnia on Hypoglossal Nerve Stimulation Outcomes in the ADHERE Registry

In reference to Impact of Insomnia on Hypoglossal Nerve Stimulation Outcomes in the ADHERE Registry Patil et al. recently concluded that individuals with moderate to severe insomnia treated with unilateral hypoglossal nerve stimulation (HNS) for obstructive sleep apnea (OSA) had similar OSA improvements and HNS adherence, with greater improvement in daytime sleepiness, compared with those with no or borderline insomnia.1 This letter expresses my concern that the study was not able to define insomnia well in this population, negating the study's findings.The research question is clinically relevant, for two reasons: (1) OSA and difficulty initiating and/or maintaining sleep (DIMS) are not only common independently but also frequently comorbid (COMISA, or comorbid insomnia and OSA); and (2) substantial DIMS can present unique challenges for HNS adherence. The latter concern arises because HNS produces repeated tongue movement with each breathing cycle that ideally start only once a patient is asleep because otherwise the movement generally interferes with falling asleep. As HNS systems do not detect sleep specifically, systems are ideally programmed accordingly (using start delay and pause time in the technology currently approved by the US Food and Drug Administration). Irregular patterns of sleep initiation and maintenance can make this programming more challenging or nearly impossible.Patil et al. examined data from the large ADHERE Registry that incorporates the Insomnia Severity Index (ISI), with an ISI score ≥15 defining moderate to severe insomnia. Unfortunately, ISI validation has been performed solely with a chief complaint of insomnia; many questions that are broadly applicable to all sleep disorders.2 Of the seven ISI questions, four (16 points) refer to any “sleep problem”, making a threshold cutoff of 15 likely neither sensitive nor specific for an insomnia diagnosis with coexisting moderate to severe OSA.Unfortunately, the lack of a good measure of insomnia severity in OSA patients at this time prevents scientific evaluation. Many colleagues (surgeons and non‐surgeons alike) recommend caution in recommending HNS to those with uncontrolled, irregular DIMS based on our shared inability to achieve adequate adherence in spite of best efforts. This letter is not meant to criticize HNS, as I have seen tremendous benefits in my own patients and have enrolled many in the ADHERE Registry study. However, we have led multicenter studies (with one author from this paper) examining predictors of HNS outcomes3,4 in same spirit as this letter: the belief that refining the selection of HNS candidates can improve outcomes and ensure that this important treatment modality remains available to help patients with OSA.BIBLIOGRAPHYDhanda Patil R, Ishman SL, Chang JL, Thaler E, Suurna MV. Impact of insomnia on hypoglossal nerve stimulation outcomes in the ADHERE registry. Laryngoscope. 2024;134:471‐479.Bastien CH, Vallières A, Morin CM. Validation of the insomnia severity index as an outcome measure for insomnia research. Sleep Med. 2001;2:297‐307.Huyett P, Kent DT, D'Agostino MA, et al. Drug‐induced sleep endoscopy and hypoglossal nerve stimulation outcomes: a multicenter cohort study. Laryngoscope. 2021;131:1676‐1682.Kedarisetty S, Sharma A, Commesso EA, et al. Palate shape is associated with unilateral hypoglossal nerve stimulation outcomes. Laryngoscope. 2024;134:981‐986. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png The Laryngoscope Wiley

In reference to Impact of Insomnia on Hypoglossal Nerve Stimulation Outcomes in the ADHERE Registry

Kezirian, Eric J.
The Laryngoscope , Volume 134 (8) – Aug 1, 2024
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References (8)

Publisher
Wiley
Copyright
© 2024 The American Laryngological, Rhinological and Otological Society, Inc.
ISSN
0023-852X
eISSN
1531-4995
DOI
10.1002/lary.31411
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Abstract

Patil et al. recently concluded that individuals with moderate to severe insomnia treated with unilateral hypoglossal nerve stimulation (HNS) for obstructive sleep apnea (OSA) had similar OSA improvements and HNS adherence, with greater improvement in daytime sleepiness, compared with those with no or borderline insomnia.1 This letter expresses my concern that the study was not able to define insomnia well in this population, negating the study's findings.The research question is clinically relevant, for two reasons: (1) OSA and difficulty initiating and/or maintaining sleep (DIMS) are not only common independently but also frequently comorbid (COMISA, or comorbid insomnia and OSA); and (2) substantial DIMS can present unique challenges for HNS adherence. The latter concern arises because HNS produces repeated tongue movement with each breathing cycle that ideally start only once a patient is asleep because otherwise the movement generally interferes with falling asleep. As HNS systems do not detect sleep specifically, systems are ideally programmed accordingly (using start delay and pause time in the technology currently approved by the US Food and Drug Administration). Irregular patterns of sleep initiation and maintenance can make this programming more challenging or nearly impossible.Patil et al. examined data from the large ADHERE Registry that incorporates the Insomnia Severity Index (ISI), with an ISI score ≥15 defining moderate to severe insomnia. Unfortunately, ISI validation has been performed solely with a chief complaint of insomnia; many questions that are broadly applicable to all sleep disorders.2 Of the seven ISI questions, four (16 points) refer to any “sleep problem”, making a threshold cutoff of 15 likely neither sensitive nor specific for an insomnia diagnosis with coexisting moderate to severe OSA.Unfortunately, the lack of a good measure of insomnia severity in OSA patients at this time prevents scientific evaluation. Many colleagues (surgeons and non‐surgeons alike) recommend caution in recommending HNS to those with uncontrolled, irregular DIMS based on our shared inability to achieve adequate adherence in spite of best efforts. This letter is not meant to criticize HNS, as I have seen tremendous benefits in my own patients and have enrolled many in the ADHERE Registry study. However, we have led multicenter studies (with one author from this paper) examining predictors of HNS outcomes3,4 in same spirit as this letter: the belief that refining the selection of HNS candidates can improve outcomes and ensure that this important treatment modality remains available to help patients with OSA.BIBLIOGRAPHYDhanda Patil R, Ishman SL, Chang JL, Thaler E, Suurna MV. Impact of insomnia on hypoglossal nerve stimulation outcomes in the ADHERE registry. Laryngoscope. 2024;134:471‐479.Bastien CH, Vallières A, Morin CM. Validation of the insomnia severity index as an outcome measure for insomnia research. Sleep Med. 2001;2:297‐307.Huyett P, Kent DT, D'Agostino MA, et al. Drug‐induced sleep endoscopy and hypoglossal nerve stimulation outcomes: a multicenter cohort study. Laryngoscope. 2021;131:1676‐1682.Kedarisetty S, Sharma A, Commesso EA, et al. Palate shape is associated with unilateral hypoglossal nerve stimulation outcomes. Laryngoscope. 2024;134:981‐986.

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The Laryngoscope – Wiley

Published: Aug 1, 2024

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