Investigation of a novel obstructive sleep apnea therapeutic method

Not Applicable

• Conditions: Obstructive sleep apnea; Respiratory - Sleep apnoea

• Registration Number: ACTRN12622001518752
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

The main research question was in relation to reducing the CPAP titration pressure and stimulating saliva secretion by using pressure oscillation. CPAP is a device that blows air into the upper airway. However, the high value of the pressure causes dryness of the upper airway, nose soreness, and irritation of the throat. 15 OSA participants were recruited (2 females and 13 males ), their age were between 47 and 79 years old. all of them were from New Zealand. They underwent two night trials. the 1st trial was done using reduced CPAP pressure and the second night was done by using the same reduced CPAP pressure with pressure oscillations. This work enhances the efficacy of CPAP therapy among OSA patients. The limitations of this study was participants movement during sleep leading to mask's air leak.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2019-03-19
• Study Start: 2022-12-06
• Last Update Posted: 9 January 2023

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

1.Age is 18 years or older.
2.Participants with Apnea–Hypopnea Index (AHI) with more than 5 events per hour.
3.Participants who are using CPAP only.
4.Good tolerance to CPAP (More than 4 hours a night on average over the last 3 months).
5.Participants who are using full face mask.

Exclusion Criteria

1.Participants with insomnia or other sleep disorders.
2.Participants who have had any surgical intervention as a treatment for obstructive sleep apnea.
3.Participants who have had metallic implants through their upper airways.
4.Participants with pacemakers.
5.Participants who are pregnant or think they may be pregnant.
6.Participants who are using APAP, BiPAP, or any other devices rather than CPAP.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of upper airway obstructions in supine position recorded by the Polysomnography.<br>[Immediately while using the device];The saliva volume were recorded without humidification[Immediately after using the device ];Sleeping comfort assessed using a 5-point Likert scale[immediately after using the device ]

Secondary Outcome Measures

Name	Time	Method
The Respiratory arousal index recorded by the polysomnography [Immediately after using the device];oxygen desaturation index recorded by the polysomnography <br>[immediately whole using the device ];Apnoea-hypopnoea index in supine sleeping position recorded by the polysomnography[immediately after using the device ];Rapid eye movement (REM) apnoea-hypopnoea index recorded by the polysomnography[immediately after using the device];Non-REM (NREM) apnoea-hypopnoea index recorded by the polysomnography'<br>[immediately after using the device ];Non-supine apnoea-hypopnoea index recorded by the polysomnography[immediately after using the device]