Design and rationale for the treating Obstructive Sleep Apnea using Targeted Hypoglossal Nerve Stimulation (OSPREY) trial.
Adaptive design
Controlled trial
Hypoglossal nerve
Neurostimulation
Obstructive sleep apnea
Randomized
Sleep
Surgical treatment
Targeted hypoglossal nerve stimulation
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
08 2022
08 2022
Historique:
received:
07
02
2022
revised:
15
05
2022
accepted:
18
05
2022
pubmed:
26
5
2022
medline:
31
8
2022
entrez:
25
5
2022
Statut:
ppublish
Résumé
Obstructive sleep apnea (OSA) affects nearly 1 billion people worldwide, including approximately 35 million US residents. OSA has detrimental cardiovascular and neurocognitive consequences. Positive airway pressure corrects sleep disordered breathing but is not always tolerated or used sufficiently. Oral appliances and surgery provide alternatives in select populations but are variably effective. Hypoglossal nerve stimulation can effectively treat obstructive sleep apnea. Targeted hypoglossal nerve stimulation (THN) is simpler than incumbent technology with no sensor and an easier, proximal electrode implantation. The third clinical study of THN, THN3, was the first randomized, controlled trial of hypoglossal nerve stimulation to demonstrate significant improvement of sleep disordered breathing in OSA. The present investigation reports the design of a novel trial of targeted stimulation to provide additional Level 1 evidence in moderate to severe obstructive apnea. OSPREY is a randomized, parallel-arm, 13-month trial wherein all subjects are implanted, 2/3 are activated at Month 1 ("Treatment") and 1/3 are activated at Month 7 ("Control"). The primary endpoint is the difference in apnea-hypopnea index response rates between Treatment and Control groups at Month 7. Secondary endpoints include quality of life and oximetry metrics. OSPREY follows an adaptive "Goldilocks" design which optimizes the number of subjects with the need for high-confidence results. A maximum of 150 subjects is allowed, at which study power of >95% is predicted. Interim analyses begin once 50 patients are randomized and recur after each 20 additional randomizations to detect early success or futility. OSPREY is a unique, efficient trial that should provide high-confidence confirmation of the safety and efficacy of targeted hypoglossal nerve stimulation for moderate to severe obstructive sleep apnea.
Identifiants
pubmed: 35613672
pii: S1551-7144(22)00130-6
doi: 10.1016/j.cct.2022.106804
pmc: PMC9420766
mid: NIHMS1811173
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04950894']
Types de publication
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106804Subventions
Organisme : NHLBI NIH HHS
ID : R01 HL157985
Pays : United States
Organisme : NHLBI NIH HHS
ID : T32 HL134632
Pays : United States
Organisme : NHLBI NIH HHS
ID : K24 HL132105
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL085188
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG063925
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL154926
Pays : United States
Organisme : NHLBI NIH HHS
ID : R01 HL148436
Pays : United States
Informations de copyright
Copyright © 2022 The Authors. Published by Elsevier Inc. All rights reserved.
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