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

NCT ID: NCT02368639

Last Updated: 2017-08-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-03-31

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.

Conditions

Sleep Apnea, Obstructive; Obesity Hypoventilation Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Positive airway pressure (PAP) device

Fisher \& 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.

Group Type: EXPERIMENTAL

Fisher & Paykel Healthcare PAP Device

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fisher and Paykel Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fisher & Paykel Healthcare Sleep Laboratory

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

CIA-156

Identifier Type: -

Identifier Source: org_study_id