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

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01553383
• Other study ID #: CREC2012.037
• Status: Completed
• Phase: N/A
• First received: March 1, 2012
• Last updated: April 5, 2013
• Start date: February 2012
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adverse Effects
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Device:
• nasal peep valve "Provent"
application of nasal peep valve vs dental device and cpap

Locations

Country	Name	City	State
Hong Kong	Department of Medicine and Therapeutics, Prince of Wales Hospital, CUHK	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea Hypopnea Index (AHI)		1 month	No
Secondary	side effects as a measure of tolerability		1 month	No