Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing

Not Applicable

Terminated

• Conditions: Obesity Hypoventilation Syndrome; Sleep Apnea, Obstructive
• Interventions: Device: Fisher & Paykel Healthcare PAP Device

• Registration Number: NCT02368639
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

This study will use a modified version of a positive airway pressure device to supply air to the participant, while undergoing supervised polysomnography. Positive airway pressures are typically applied to many patients with hypoventilation, in this study these pressures will be titrated by a qualified sleep technician. During the night these pressures will be altered to optimise comfort.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-02-08
• Study First Submitted QC: 2015-02-15
• Study First Posted: 2015-02-23
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Aged 18+
• Patients diagnosed with obesity hypoventilation syndrome (OHS) and/or obstructive sleep apnea (OSA) by a practicing sleep or respiratory physician, requiring positive airway pressure (PAP) therapy

Exclusion Criteria

• Recent cardiac or respiratory arrest
• Gastro intestinal bleeding, ileus or recent gastrointestinal surgery
• Coma, decreased level of consciousness or agitation
• Anatomical or subjective difficulty with airway access e.g. facial surgery, trauma, vomiting upper airway obstruction
• Cerebrospinal fluid leak, abnormalities of the cribiform plate or prior history of head trauma.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Positive airway pressure (PAP) device	Fisher & Paykel Healthcare PAP Device	Fisher \& Paykel Healthcare PAP Device. Participants will sleep overnight using themodified positive airway pressure device. Their pressures will be titrated by a qualified sleep technician, they will then be optimised during the night.

Primary Outcome Measures

Name	Time	Method
Apnea hypopnea index (AHI)	8 hours	The number of apnea and hypopneas will be measured
Peripheral blood oxygen level (SpO2)	8 hours	Peripheral blood oxygen level will be measured

Trial Locations

Locations (1)

Fisher & Paykel Healthcare Sleep Laboratory; 🇳🇿 Auckland, New Zealand