NCT04626700|Unknown
Comparison for Oral Negative Pressure Therapy and CPAP for OSA Under Sleep Endoscopy Assistance: A Randomized Controlled Trial
Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch
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Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch
Sponsor study identifier
interventional
60
1 country
1
Study Start
August 14, 2019
Actual (reported)Primary Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 14, 2019
Actual (reported)November 1, 2020
Actual (reported)November 12, 2020
Actual (reported)June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The Epworth Sleepiness Scale (ESS)
lower ESS means better outcome
Change from Baseline ESS at 1 month
The Epworth Sleepiness Scale (ESS)
lower ESS means better outcome
Change from Baseline ESS at 2 months
apnea-hypopnea index (AHI)
lower AHI means better outcome
Change from Baseline AHI at 2 months
iNAP for the treatment of OSA
CPAP for the treatment of OSA
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Division of Thoracic Medicine, Chang Gung Memorial Hospital
Taipei, 105, Taiwan
Tsang-Tang Hsieh, MD
Institutional Review Board Chang Gung Medical Foundation
First Submitted
November 1, 2020
First Posted
November 12, 2020
Study Start
August 14, 2019
Actual (reported)Primary Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Validation of Sleep Healthcare System
Contact the study team to confirm eligibility.
Study Completion
June 30, 2022
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
November 12, 2020
Record last verified: 2020-10
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Source: ClinicalTrials.gov.
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