Feasibility of a Modified Positive Airway Pressure Device to Treat Sleep Disordered Breathing
Not Applicable
Terminated
- Conditions
- Obesity Hypoventilation SyndromeSleep Apnea, Obstructive
- 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
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
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Fisher & Paykel Healthcare Sleep Laboratory
🇳🇿Auckland, New Zealand
Fisher & Paykel Healthcare Sleep Laboratory🇳🇿Auckland, New Zealand