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
1 other identifier
interventional
60
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2019
CompletedFirst Submitted
Initial submission to the registry
November 1, 2020
CompletedFirst Posted
Study publicly available on registry
November 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2022
CompletedNovember 12, 2020
October 1, 2020
2.9 years
November 1, 2020
November 6, 2020
Conditions
Outcome Measures
Primary Outcomes (3)
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
Study Arms (2)
iNAP
EXPERIMENTALCPAP
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- mild to moderate OSA
You may not qualify if:
- hypopharynx obstruction
- ASA classification of physical status)\>3
- allergy toDexmedetomidine
- COPD stage IV
- Asthma with exacerbation
- severe CHF
- age \< 18 year-old
- claustraphobia
- any reason : can not tolerate CPAP
- second or third degree AVB
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Division of Thoracic Medicine, Chang Gung Memorial Hospital
Taipei, 105, Taiwan
Study Officials
- STUDY CHAIR
Tsang-Tang Hsieh, MD
Institutional Review Board Chang Gung Medical Foundation
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2020
First Posted
November 12, 2020
Study Start
August 14, 2019
Primary Completion
June 30, 2022
Study Completion
June 30, 2022
Last Updated
November 12, 2020
Record last verified: 2020-10