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

NCT ID: NCT04626700

Last Updated: 2020-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-14

Study Completion Date

2022-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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OSA iNAP DISE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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iNAP

Group Type EXPERIMENTAL

iNAP

Intervention Type DEVICE

iNAP for the treatment of OSA

CPAP

Group Type ACTIVE_COMPARATOR

CPAP

Intervention Type DEVICE

CPAP for the treatment of OSA

Interventions

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iNAP

iNAP for the treatment of OSA

Intervention Type DEVICE

CPAP

CPAP for the treatment of OSA

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chang Gung Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tsang-Tang Hsieh, MD

Role: STUDY_CHAIR

Institutional Review Board Chang Gung Medical Foundation

Locations

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Division of Thoracic Medicine, Chang Gung Memorial Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Tsai-Yu Wang, MD

Role: CONTACT

Phone: +886975368076

Email: [email protected]

Facility Contacts

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TSAI-YU WANG, MD

Role: primary

Other Identifiers

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201802177A3

Identifier Type: -

Identifier Source: org_study_id