Obesity Hypoventilation Syndrome, Sleep Apnea, Obstructive
Conditions
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.
Interventions
DEVICEFisher & Paykel Healthcare PAP Device
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.
Sponsors
Fisher and Paykel Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
New Zealand
Outcome results
None listed