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

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.

Study Overview

• Status: Terminated
• Conditions: Sleep Apnea, Obstructive; Obesity Hypoventilation Syndrome
• Intervention / Treatment: Device: Fisher & Paykel Healthcare PAP Device

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland, New Zealand
    • Fisher & Paykel Healthcare Sleep Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Apnea hypopnea index (AHI)	The number of apnea and hypopneas will be measured	8 hours
Peripheral blood oxygen level (SpO2)	Peripheral blood oxygen level will be measured	8 hours

Collaborators and Investigators

• Sponsor: Fisher and Paykel Healthcare

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: February 8, 2015
• First Submitted That Met QC Criteria: February 15, 2015
• First Posted (Estimate): February 23, 2015

Study Record Updates

• Last Update Posted (Actual): August 11, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Overnutrition; Nutrition Disorders; Signs and Symptoms, Respiratory; Respiratory Insufficiency; Obesity; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Hypoventilation; Obesity Hypoventilation Syndrome
• Other Study ID Numbers: CIA-156

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No