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NCT04729478

Comparison Between Natural Sleep Endoscopy and Drug-induced Sleep Endoscopy in Patients With Obstructive Sleep Apnea

Status unknown NA Last updated 26 July 2021
What this trial tests

NA trial testing Drug-induced sleep endoscopy in Sleep Apnea, Obstructive in 40 participants. Status unknown.

Timeline
30 March 2021
Primary endpoint
31 August 2022
31 December 2022

Quick facts

Lead sponsorethisch.comite@uza.be
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingsingle
Primary purposediagnostic
Enrollment40
Start date30 March 2021
Primary completion31 August 2022
Estimated completion31 December 2022
Sites1 location across Belgium

Drugs / interventions tested

Conditions studied

Sponsor

ethisch.comite@uza.be

Who can join

18 and older, any sex, with Sleep Apnea, Obstructive or Sleep Apnea. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Drug-induced sleep endoscopy (DISE) is the most used technique for identifying the obstruction site associated with obstructive sleep apnea (OSA). This is due to the fact that it allows many patients to be examined in a daytime setting. This procedure uses sedative drugs to mimic natural sleep. However, associations with the site of upper airway (UA) collapse during natural sleep remain unclear. The aim of this explorative study is to identify UA collapse in patients with OSA using endoscopic techniques as well as flow shape characteristics and sound analyses during natural and drug-induced sleep. Furthermore, we want to optimize the measurement set-up of natural sleep endoscopy (NSE).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Comparison of Drug-Induced Sleep Endoscopy and Natural Sleep Endoscopy in the Assessment of Upper Airway Pathophysiology During Sleep: Protocol and Study Design.
    Van den Bossche K, Van de Perck E, Wellman A, Kazemeini E, et al · · 2021 · cited 6× · PMID 34950101 · DOI 10.3389/fneur.2021.768973

Verify or expand the search:

Other recruiting trials for Sleep Apnea, Obstructive

Currently open trials in the same condition.

Other ethisch.comite@uza.be trials

Trials by the same sponsor.

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Data sources for this page

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