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

Sleep Apnea, Obstructive Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02368639
• Other study ID #: CIA-156
• Status: Terminated
• Phase: N/A
• First received: February 8, 2015
• Last updated: August 9, 2017
• Start date: January 2015
• Est. completion date: March 2016

Study information

• Verified date: August 2017
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypoventilation
• Obesity Hypoventilation Syndrome
• Sleep Apnea, Obstructive

Intervention

Device:
• Fisher & 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.

Locations

Country	Name	City	State
New Zealand	Fisher & Paykel Healthcare Sleep Laboratory	Auckland

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apnea hypopnea index (AHI)	The number of apnea and hypopneas will be measured	8 hours
Primary	Peripheral blood oxygen level (SpO2)	Peripheral blood oxygen level will be measured	8 hours