Back to resultsComparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for Obstructive Sleep Apnea
Primary Purpose
Obstructive Sleep Apnea, Adverse Effects
Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
nasal peep valve "Provent"
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA
Eligibility Criteria
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.
Sites / Locations
- Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Dental device
CPAP
Arm Description
"Provent" nasal peep valve vs dental device
continuous positive airway pressure "CPAP" vs nasap peep valve "Provent"
Outcomes
Primary Outcome Measures
Apnea Hypopnea Index (AHI)
Secondary Outcome Measures
side effects as a measure of tolerability
Full Information
NCT ID
NCT01553383
First Posted
March 1, 2012
Last Updated
April 5, 2013
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01553383
Brief Title
Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for Obstructive Sleep Apnea
Official Title
Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for OSA
Study Type
Interventional
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Adverse Effects
Keywords
OSA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dental device
Arm Type
Active Comparator
Arm Description
"Provent" nasal peep valve vs dental device
Arm Title
CPAP
Arm Type
Active Comparator
Arm Description
continuous positive airway pressure "CPAP" vs nasap peep valve "Provent"
Intervention Type
Device
Intervention Name(s)
nasal peep valve "Provent"
Intervention Description
application of nasal peep valve vs dental device and cpap
Primary Outcome Measure Information:
Title
Apnea Hypopnea Index (AHI)
Time Frame
1 month
Secondary Outcome Measure Information:
Title
side effects as a measure of tolerability
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK
City
Shatin
Country
Hong Kong
12. IPD Sharing Statement
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Comparison of Nasal Positive End Expiratory Pressure Valve to Dental Device as an Alternative Treatment for Obstructive Sleep Apnea
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