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

Fisher and Paykel Healthcare1 site in 1 country14 target enrollmentJanuary 2015

ConditionsSleep Apnea, Obstructive Obesity Hypoventilation Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Sleep Apnea, Obstructive
Sponsor: Fisher and Paykel Healthcare
Enrollment: 14
Locations: 1
Primary Endpoint: Apnea hypopnea index (AHI)
Status: Terminated
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2015

End Date

March 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fisher and Paykel Healthcare

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.