Pilot Study of prototype Intranasal Stent & Positive Expiratory Airway Pressure device to treat Moderate Obstructive Sleep Apnoea

Phase 1

• Conditions: Obstructive Sleep Apnoea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12615000572561
• Lead Sponsor: Monash Lung and Sleep

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-06-03
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Moderate obstructive sleep apnoea (apnoea hypopnoea index >15 events per hour and <30 events per hour).

- Witness in the domestic environment to report on snoring severity.

Exclusion Criteria

- Unable to fit intranasal stent device comfortably
- Unable to provide informed consent
- Major cardiorespiratory comorbidity
- Current treatment for obstructive sleep apnoea

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the effect of an intranasal expiratory pressure device on moderate obstructive sleep apnoea measured by in laboratory polysomnography[Device response is measured by polysomnography on first night of use. Pilot data measuring self reports of nightly usage will be collected for 14 consecutive nights]

Secondary Outcome Measures

Name	Time	Method
Tolerability of an intranasal expiratory pressure device used nightly for 14 trial nights in the domestic environment. This will be determined by a subjective report using 5 point visual analogue scale of comfort and self report of hours of usage per night.[After 14 days of home usage during sleep];Partner assisted self report of subjective snoring severity measured by an analogue scale[Data will be collected daily for 14 trial days]