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

Primary Purpose

Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome

Status
Terminated
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
Fisher & Paykel Healthcare PAP Device
Sponsored by
Fisher and Paykel Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Apnea, Obstructive

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fisher & Paykel Healthcare Sleep Laboratory

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Positive airway pressure (PAP) device

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 8, 2015
Last Updated
August 9, 2017
Sponsor
Fisher and Paykel Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT02368639
Brief Title
Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
Official Title
Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to recruitment slower than anticipated
Study Start Date
January 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fisher and Paykel Healthcare

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Apnea, Obstructive, Obesity Hypoventilation Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Positive airway pressure (PAP) device
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Fisher & Paykel Healthcare PAP Device
Intervention Description
The device is a modified version of the Fisher & Paykel Icon continuous positive airway pressure (CPAP) device, which is a fully released product in New Zealand.
Primary Outcome Measure Information:
Title
Apnea hypopnea index (AHI)
Description
The number of apnea and hypopneas will be measured
Time Frame
8 hours
Title
Peripheral blood oxygen level (SpO2)
Description
Peripheral blood oxygen level will be measured
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Fisher & Paykel Healthcare Sleep Laboratory
City
Auckland
Country
New Zealand

12. IPD Sharing Statement

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

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