Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.

March 13, 2017 updated by: Fisher and Paykel Healthcare

Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea, in Comparison to a Market Released Device.

This study will test the hypothesis that the modified positive airway pressure (PAP) device for OSA will be no worse than a market released product in terms of its treatment efficacy, comfort and patient compliance. Patients will have their treatment pressure titrated using polysomnography (PSG) in the sleep laboratory, and then in a random order will spend additional time undergoing PSG using both devices, and using both devices at home for 3 weeks. Data will be collected from the PSG studies, device downloads, independent pressure-flow loggers, and custom questionnaires.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The study will be held in two parts. The main portion of the study which compares the modified PAP device and the market released product including the laboratory testing and home testing of the devices will be called 'Part A'. Additional nights using the PAP device with PSG monitoring will be used to gather additional observational flow data to allow distortion testing and investigation of the FPH (Fisher & Paykel Healthcare) SensAwake (an unique feature which automatically lowers the pressure when a patient wakes up) algorithm while using PAP, this is part B.

Part A After the patient has undergone informed consent, their demographic and clinical variables will be collected and entered into a case report form (CRF) before any setup procedure is started. The patient will be asked to complete questionnaires regarding their normal therapy (ESS (Epworth Sleepiness Score), FOSQ (Functional Outcomes of Sleep Questionnaire), custom therapy comfort questionnaire), and then will be set up for a standard PSG. The patient will use their prescribed mask and a clean water chamber and breathing tube which will be connected to the modified PAP device. The patients will sleep on the device throughout the night while having their PAP titrated by a qualified sleep technician. Pressure titration is necessary for two reasons: firstly, it may have been a period of time since the participants last titration, and secondly this version of PAP involves the use of different levels of pressure. Pressures will be titrated according to the AASM (American Academy of Sleep Medicine) Clinical Guidelines for the Manual Titration of Positive Airway Pressure in Patients with OSA.

The participant will be randomized to either the modified PAP or market released device group. They will be issued with a PAP device and a pressure-flow logger to be used at home in the usual manner of their PAP therapy for 3 weeks (+/- 4 days), after which participants will return to the FPH sleep laboratory to participate in a overnight PSG study using their first device. At this visit the participant will also swap to the second PAP device; and the above home use repeated on device 2.

Part B After informed consent form the patient will be set up for a standard PSG, and sleep overnight using the modified PAP device, their prescribed mask, and a clean water chamber and breathing tube. This testing will be performed to provide additional flow data to the development engineers. This includes, but is not limited to, distortion testing and adjustment of device parameters during the sleep study. Distortion testing analyses the impact of the PAP pressure changes on the participants breathing or airflow.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Auckland, New Zealand, 2013
        • Fisher & Paykel Healthcare

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged 18+
  • Diagnosed with OSA by a practicing sleep physician

Exclusion Criteria:

  • Patients with a known history of Cerebrospinal fluid leak, abnormalities of the cribriform plate, head trauma and/or pneumocephalus
  • Patients with pathologically low blood pressure, pneumothorax, a previous history of pneumothorax, or dehydration.
  • Patient with bypassed upper airway
  • Other significant sleep disorder(s) (e.g. periodic leg movements, insomnia, central sleep apnea)
  • Previous use of a bi-level device with-in the last 2 years (from enrolment date).
  • Patients with respiratory failure, bullous lung disease or COPD (Chronic Obstructive Pulmonary Disease).
  • Patients with obesity hypoventilation syndrome or congestive heart failure
  • Patients that require supplemental oxygen with their CPAP (Continuous Positive Airway Pressure) device
  • Patients with implanted or life-supporting electronic medical devices (e.g. cardiac pacemakers)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Market released PAP device
Use of a market released PAP device
Experimental: Modified PAP device
Us of the modified PAP device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAP Treatment Efficacy
Time Frame: After 1 night in the sleep lab and 3 weeks use of the device in the home.
The participants apnea hypopnea index (AHI) will be assessed using the PSG data, device download data and the independent pressure-flow logger. The apnea-hypopnea index is the total number of sleep disordered breathing events divided by total sleep time.
After 1 night in the sleep lab and 3 weeks use of the device in the home.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PAP Treatment Comfort
Time Frame: After 1 night in the sleep lab and 3 weeks use of the device in the home.
Participants will be administered comfort questionnaires regarding the comfort of all devices. The range of responses is 1 to 5 with 1 being very uncomfortable to 5 being very comfortable.
After 1 night in the sleep lab and 3 weeks use of the device in the home.
PAP Compliance
Time Frame: After 1 night in the sleep lab and 3 weeks use of the device in the home.
Participants therapy utilisation will be compared between the two devices using the device data download, and the independent pressure-flow logger.
After 1 night in the sleep lab and 3 weeks use of the device in the home.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Hanie Yee, Fisher & Paykel Healthcare

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 10, 2014

First Submitted That Met QC Criteria

August 10, 2014

First Posted (Estimate)

August 12, 2014

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

March 13, 2017

Last Verified

March 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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