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

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ClinicalTrials.gov Identifier: NCT02214238
Recruitment Status : Completed
First Posted : August 12, 2014
Results First Posted : April 24, 2017
Last Update Posted : April 24, 2017
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Brief Summary:
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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea (OSA) Device: PAP device

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  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : August 2014
Primary Completion Date : November 2015
Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Market released PAP device
Use of a market released PAP device
Device: PAP device
Experimental: Modified PAP device
Us of the modified PAP device
Device: PAP device

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214238

New Zealand
Fisher & Paykel Healthcare
Auckland, New Zealand, 2013
Sponsors and Collaborators
Fisher and Paykel Healthcare
Study Director: Hanie Yee Fisher & Paykel Healthcare

Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02214238     History of Changes
Other Study ID Numbers: CIA-116
First Posted: August 12, 2014    Key Record Dates
Results First Posted: April 24, 2017
Last Update Posted: April 24, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases