Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for Obstructive Sleep Apnea

NCT ID: NCT01553383

Last Updated: 2013-04-08

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

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-03-31

Brief Summary

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Determine the clinical efficacy in terms of Apnea Hypopnea Index (AHI), excessive daytime sleepiness (EDS), nocturnal oxygenation of a nasal Positive end-expiratory pressure (PEEP) valve "Provent" in obstructive sleep apnea. The hypothesis is the efficacy will be better than dental device.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Adverse Effects

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dental device

"Provent" nasal peep valve vs dental device

Group Type ACTIVE_COMPARATOR

nasal peep valve "Provent"

Intervention Type DEVICE

application of nasal peep valve vs dental device and cpap

CPAP

continuous positive airway pressure "CPAP" vs nasap peep valve "Provent"

Group Type ACTIVE_COMPARATOR

nasal peep valve "Provent"

Intervention Type DEVICE

application of nasal peep valve vs dental device and cpap

Interventions

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nasal peep valve "Provent"

application of nasal peep valve vs dental device and cpap

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Symptomatic patients confirmed of OSA by sleep study (PSG according to AASM criteria or validated level 3 portable monitoring devices with AHI \> 10/hr)
* Not using CPAP for any reasons or patients on dental device but would like to try alternative treatments for OSA.
* Able to sign informed consent and use the PEEP nasal valve.
* Age between 18-65 years old.
* Willing to attend follow up.

Exclusion Criteria

* Known nasal problems like deformities or significant rhinitis affecting application of PEEP nasal valve.
* Unable to sign consent or use PEEP nasal valve.
* Significant or unstable co-morbidities requiring other forms of treatment for OSA as priority.
* Coexisting sleep disordered breathing condition other than OSA requiring more complex treatment. E.g. central sleep apnea, significant Cheyne Stokes respiration or hypoventilation syndrome.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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To Kin Wang

Associate consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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CREC2012.037

Identifier Type: -

Identifier Source: org_study_id

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