Study Stopped
The study was terminated due to recruitment slower than anticipated
Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 8, 2015
CompletedFirst Posted
Study publicly available on registry
February 23, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedAugust 11, 2017
August 1, 2017
1.2 years
February 8, 2015
August 9, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
Apnea hypopnea index (AHI)
The number of apnea and hypopneas will be measured
8 hours
Peripheral blood oxygen level (SpO2)
Peripheral blood oxygen level will be measured
8 hours
Study Arms (1)
Positive airway pressure (PAP) device
EXPERIMENTALFisher \& 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fisher & Paykel Healthcare Sleep Laboratory
Auckland, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2015
First Posted
February 23, 2015
Study Start
January 1, 2015
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 11, 2017
Record last verified: 2017-08