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NCT04626700

Comparison for Oral Negative Pressure Therapy and CPAP for OSA Under Sleep Endoscopy Assistance: A Randomized Controlled Trial

Status unknown NA Last updated 12 November 2020
What this trial tests

NA trial testing iNAP in OSA in 60 participants. Status unknown.

Timeline
14 August 2019
Primary endpoint
30 June 2022
30 June 2022

Quick facts

Lead sponsorChang Gung Memorial Hospital
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment60
Start date14 August 2019
Primary completion30 June 2022
Estimated completion30 June 2022
Sites1 location across Taiwan

Drugs / interventions tested

Conditions studied

Sponsor

Chang Gung Memorial Hospital

Who can join

Adults 18 to 100, any sex, with OSA or iNAP. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is the study entitled "Comparison for oral negative pressure therapy and CPAP for OSA under sleep endoscopy assistance: A randomized controlled trial". CPAP is first line golden standard treatment for Obstructive sleep apnea (OSA). However, the overall CPAP compliance is poor. Recent study reveals that oral negative pressure therapy improves apnea severity in OSA patients with good compliance. However, no study is designed to compare oral negative pressure therapy and CPAP for OSA patients. In addition, the effect of oral negative pressure therapy for hypopharynx is unclear. Therefore, we will perform druginduced sleep endoscopy to evaluate upper airway obstruction of OSA patients before treatment. OSA patients will be assigned into oral negative pressure group or CPAP group for 2 months. Sleepiness, sleep quality, residual apnea severity and compliance will be evaluated.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for OSA

Currently open trials in the same condition.

Other Chang Gung Memorial Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04626700.

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