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Clinical Trials/ISRCTN04363711
ISRCTN04363711
Completed
Not Applicable

Evaluation of fixed continuous positive airway pressure (CPAP) with C-Flex+ against fixed CPAP in patients with obstructive sleep apnoea

Philips Respironics (France)0 sites85 target enrollmentJanuary 13, 2011
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ConditionsObstructive sleep apnoeaNervous System DiseasesSleep disorders

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive sleep apnoea
Sponsor
Philips Respironics (France)
Enrollment
85
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
January 13, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Philips Respironics (France)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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