Dataset Information

Relation between arousability and outcome of upper airway stimulation in the Stimulation for Apnea Reduction (STAR) Trial.

ABSTRACT:

Study objectives

Upper airway stimulation (UAS) is an innovative surgical treatment for obstructive sleep apnea; however, the treatment failure rate is approximately 22%. Easy arousability may limit the tolerability of stimulation and, by extension, its effectiveness. The odds ratio product (ORP) is a continuous electroencephalographic metric of arousal propensity (range: 0 [deep sleep] to 2.5 [full wakefulness]), and its rate of decline after arousal (ORP-9) is a risk factor for susceptibility to arousal in the presence of frequent arousal stimuli. We hypothesized that individuals with deeper sleep (low average ORP and low ORP-9) are more likely to respond to UAS.

Methods

ORP and ORP-9 were calculated from 126 baseline polysomnograms of participants in the STAR Trial. These values were compared between responders and nonresponders. Adjusted linear modeling was performed to determine the association between ORP-derived variables and treatment response.

Results

No differences were found between responders and nonresponders in unadjusted comparisons of ORP-derived variables. On linear regression modeling, significant correlation was found between non-rapid eye movement ORP and reduction in apnea-hypopnea index (P = .004).

Conclusions

No significant difference in ORP was noted between responders and nonresponders to UAS therapy; however, contrary to our initial hypothesis, linear regression modeling trended toward a positive relationship between ORP and UAS response, suggesting that those who have lighter sleep are more likely to respond to therapy; however, these results are only exploratory, and future larger prospective studies are needed to confirm this relationship.

Clinical trial registration

Registry: ClinicalTrials.gov; Name: STAR Trial; Identifier: NCT01161420.

SUBMITTER: Yu JL

PROVIDER: S-EPMC8020691 | biostudies-literature | 2021 Apr

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Relation between arousability and outcome of upper airway stimulation in the Stimulation for Apnea Reduction (STAR) Trial.

Yu Jason L JL Younes Magdy M

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine 20210401 4

<h4>Study objectives</h4>Upper airway stimulation (UAS) is an innovative surgical treatment for obstructive sleep apnea; however, the treatment failure rate is approximately 22%. Easy arousability may limit the tolerability of stimulation and, by extension, its effectiveness. The odds ratio product (ORP) is a continuous electroencephalographic metric of arousal propensity (range: 0 [deep sleep] to 2.5 [full wakefulness]), and its rate of decline after arousal (ORP-9) is a risk factor for suscept ...[more]

PMID: 33295277

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Project description:ImportancePatients with Down syndrome have a high incidence of persistent obstructive sleep apnea (OSA) and limited treatment options. Upper airway hypoglossal stimulation has been shown to be effective for adults with OSA but has not yet been evaluated for pediatric populations.ObjectiveTo evaluate the safety and effectiveness of upper airway stimulation for adolescent patients with Down syndrome and severe OSA.Design, setting, and participantsThis prospective single-group multicenter cohort study with 1-year follow-up was conducted between April 1, 2015, and July 31, 2021, among a referred sample of 42 consecutive adolescent patients with Down syndrome and persistent severe OSA after adenotonsillectomy.InterventionUpper airway stimulation.Main outcomes and measuresThe prespecified primary outcomes were safety and the change in apnea-hypopnea index (AHI) from baseline to 12 months postoperatively. Polysomnographic and quality of life outcomes were assessed at 1, 2, 6, and 12 months postoperatively.ResultsAmong the 42 patients (28 male patients [66.7%]; mean [SD] age, 15.1 [3.0] years), there was a mean (SD) decrease in AHI of 12.9 (13.2) events/h (95% CI, -17.0 to -8.7 events/h). With the use of a therapy response definition of a 50% decrease in AHI, the 12-month response rate was 65.9% (27 of 41), and 73.2% of patients (30 of 41) had a 12-month AHI of less than 10 events/h. The most common complication was temporary tongue or oral discomfort, which occurred in 5 patients (11.9%). The reoperation rate was 4.8% (n = 2). The mean (SD) improvement in the OSA-18 total score was 34.8 (20.3) (95% CI, -42.1 to -27.5), and the mean (SD) improvement in the Epworth Sleepiness Scale score was 5.1 (6.9) (95% CI, -7.4 to -2.8). The mean (SD) duration of nightly therapy was 9.0 (1.8) hours, with 40 patients (95.2%) using the device at least 4 hours a night.Conclusions and relevanceUpper airway stimulation was able to be safely performed for 42 adolescents who had Down syndrome and persistent severe OSA after adenotonsillectomy with positive airway pressure intolerance. There was an acceptable adverse event profile with high rates of therapy response and quality of life improvement.Trial registrationClinicalTrials.gov Identifier: NCT02344108.

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Dataset Information

Relation between arousability and outcome of upper airway stimulation in the Stimulation for Apnea Reduction (STAR) Trial.

Study objectives

Methods

Results

Conclusions

Clinical trial registration

Publications

Relation between arousability and outcome of upper airway stimulation in the Stimulation for Apnea Reduction (STAR) Trial.

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