Study of perception of a new generation of continuous positive airway pressure (CPAP) device, PR1-PFlex

Completed

Conditions: Obstructive Sleep Apnea
Nervous System Diseases
Sleep apnoea: obstructive

Registration Number: ISRCTN50028060

Lead Sponsor: Philips Home Healthcare Solutions (France)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 110

Inclusion Criteria

1. Male or female, aged 18 years of age
2. Documented Obstructive Sleep Apnea Syndrome
3. Using CPAP with an auto-PAP mode at least 3 hours per night (data from the device)
4. CPAP should be replaced routinely by the home care provider or physician?s decision
5. Able to provide consent
6. Able to follow the instructions given by the investigator
7. Covered by National Health Insurance

Exclusion Criteria

1. PAP therapy is otherwise medically contraindicated: acute upper respiratory infection, encephalitis, sinusitis or middle ear infection or surgery of the upper airway, nose, sinus, or middle ear and any non-indications usual and described in the manual
2. Untreated non-OSA sleep disorders
3. Intake of central relevant drugs, sedatives, or other drugs which impair sleep.
4. Acute dermatitis or other skin lesions or trauma interfering with the application of a mask
5. Unwilling to participate in the study
6. Participation in another clinical study in the past 4 weeks

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is based on patient satisfaction. This satisfaction assessment will be by means of two satisfaction questionnaires (before and after use of the device Questionnaire (Questionnaire PRE-TEST and Questionnaire POST-TEST).

Secondary Outcome Measures

Name	Time	Method
The secondary endpoints of the study are:<br>1. Assessing sleepiness (Epworth scale) and sleep quality (Saint Mary's Hospital Questionnaire)<br>2. Evaluate the data recorded by the device, such as:<br>2.1. Compliance and % sleep time<br>2.2. The residual AHI<br>2.3. The P90 represents the effective pressure required to remove obstructive events during at least 90% of the night.