Evaluation of fixed continuous positive airway pressure (CPAP) with C-Flex+ against fixed CPAP

Completed

• Conditions: Obstructive sleep apnoea; Nervous System Diseases; Sleep disorders

• Registration Number: ISRCTN04363711
• Lead Sponsor: Philips Respironics (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 85

Inclusion Criteria

1. AHI greater than 15 confirmed (greater than than 50% obstructive events) by full PSG within last 14 days
2. Age greater than or equal to 21 years of age
3. Able to provide consent
4. Able to follow the instructions given by the investigator regarding using their CPAP device and their participation in this study

Exclusion Criteria

1. Inability to tolerate CPAP during the daytime CPAP session
2. Failure of CPAP to adequately treat OSA during titration (AHI greater than or equal to 15.0/h under the determined optimal pressure)
3. 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 within the previous 90 days
4. Untreated, non-OSA sleep disorders, including but not limited to; insomnia, periodic leg movements (PLM)/restless legs syndrome (RLS)
5. Treated insomnia
6. Intake of central relevant drugs, sedatives, or other drugs which impair sleep
7. Previous exposure to positive airways pressure therapy
8. Acute dermatitis or other skin lesions or trauma interfering with the application of a mask
9. Unwilling to participate in the study
10. Participation in another clinical study in the past 4 weeks
11. Shift worker

Study & Design

• Study Type: Interventional
• Study Design: Not specified