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

NCT01553383 | Completed

• 1 other identifier: CREC2012.037
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea; Adverse Effects

Keywords

OSA

Outcome Measures

Primary Outcomes (1)

• Apnea Hypopnea Index (AHI)

  1 month

Secondary Outcomes (1)

• side effects as a measure of tolerability

  1 month

Study Arms (2)

Dental device

ACTIVE COMPARATOR

"Provent" nasal peep valve vs dental device

Device: nasal peep valve "Provent"

CPAP

ACTIVE COMPARATOR

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

Device: nasal peep valve "Provent"

Interventions

nasal peep valve "Provent" DEVICE

application of nasal peep valve vs dental device and cpap

CPAP; Dental device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

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

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate consultant

Study Record Dates

• First Submitted: March 1, 2012
• First Posted: March 14, 2012
• Study Start: February 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 8, 2013

Record last verified: 2013-04

Locations

HK (1)