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
About this trial
This is an interventional treatment trial for Sleep Apnea, Obstructive
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.
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
NCT ID
NCT02368639
First Posted
February 8, 2015
Last Updated
August 9, 2017
Sponsor
Fisher and Paykel Healthcare
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
Learn more about this trial
Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
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