- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02214238
Evaluation of Treatment Efficacy and Comfort of a Modified Positive Airway Pressure Device to Treat Obstructive Sleep Apnea.
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.
Study Overview
Status
Conditions
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Auckland, New Zealand, 2013
- Fisher & Paykel Healthcare
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
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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.
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After 1 night in the sleep lab and 3 weeks use of the device in the home.
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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.
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After 1 night in the sleep lab and 3 weeks use of the device in the home.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Hanie Yee, Fisher & Paykel Healthcare
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIA-116
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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