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

April 5, 2013 updated by: To Kin Wang, Chinese University of Hong Kong

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

200

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

  • Hong Kong
      • Shatin, Hong Kong
        • Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dental device
"Provent" nasal peep valve vs dental device
Device: nasal peep valve "Provent"
application of nasal peep valve vs dental device and cpap
Active Comparator: CPAP
continuous positive airway pressure "CPAP" vs nasap peep valve "Provent"
Device: nasal peep valve "Provent"
application of nasal peep valve vs dental device and cpap

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Apnea Hypopnea Index (AHI)
Time Frame: 1 month
1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
side effects as a measure of tolerability
Time Frame: 1 month
1 month

Collaborators and Investigators

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

Sponsor

Chinese University of Hong Kong

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

February 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

March 1, 2012

First Submitted That Met QC Criteria

March 13, 2012

First Posted (Estimate)

March 14, 2012

Study Record Updates

Last Update Posted (Estimate)

April 8, 2013

Last Update Submitted That Met QC Criteria

April 5, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC2012.037

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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