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

November 6, 2020 updated by: Chang Gung Memorial Hospital

Thoracic Department, Chang Gung Memorial Hospital, Linko Main Branch

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 105
        • Recruiting
        • Division of Thoracic Medicine, Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • mild to moderate OSA

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: iNAP
Device: iNAP
iNAP for the treatment of OSA
ACTIVE_COMPARATOR: CPAP
Device: CPAP
CPAP for the treatment of OSA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Epworth Sleepiness Scale (ESS)
Time Frame: Change from Baseline ESS at 1 month
lower ESS means better outcome
Change from Baseline ESS at 1 month
The Epworth Sleepiness Scale (ESS)
Time Frame: Change from Baseline ESS at 2 months
lower ESS means better outcome
Change from Baseline ESS at 2 months
apnea-hypopnea index (AHI)
Time Frame: Change from Baseline AHI at 2 months
lower AHI means better outcome
Change from Baseline AHI at 2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 14, 2019

Primary Completion (ANTICIPATED)

June 30, 2022

Study Completion (ANTICIPATED)

June 30, 2022

Study Registration Dates

First Submitted

November 1, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (ACTUAL)

November 12, 2020

Study Record Updates

Last Update Posted (ACTUAL)

November 12, 2020

Last Update Submitted That Met QC Criteria

November 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 201802177A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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