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Clinical Trials/ISRCTN59353477
ISRCTN59353477
Completed
N/A

Treatment by uninterrupted positive airway pressure by nasal route - Evaluation of REMstar® Auto with C-Flex in clinical practice

Respironics International (France)0 sites20 target enrollmentNovember 20, 2008
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ConditionsSleep apnoea/ hypopnoea syndromeNervous System DiseasesSleep disorders

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sleep apnoea/ hypopnoea syndrome
Sponsor
Respironics International (France)
Enrollment
20
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
November 20, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
Male

Investigators

Sponsor
Respironics International (France)

Eligibility Criteria

Inclusion Criteria

  • •1\. Male adults \>18
  • •2\. Index of apnoea/ hypopnoeas \>30/hour
  • •3\. Able to provide written consent

Exclusion Criteria

  • •1\. Past experience of treatment with positive airway pressure or non invasive ventilation
  • •2\. Participants who require 2 levels of pressure for nocturnal alveolar hypoventilation linked to a co\-morbidity (obesity, hypoventilation, chronic obstructive pulmonary disease \[COPD]) of sleep aponea/ hypopnoea syndrome
  • •3\. Participants that have undergone surgery for the treatment of sleep apnoea/ hypopnoea syndrome, snore or tumour in the last 6 months or after their polysomnography (PSG) diagnosis
  • •4\. Tracheostomy
  • •5\. Respiratory infection, sinusitis or internal ear infection
  • •6\. Dermatitis or other facial lesions preventing the application of a mask
  • •7\. Unable to give written informed consent
  • •8\. Participants unwilling to volunteer
  • •9\. Unstable medication
  • •10\. Participants presenting with clinically significant COPD or unstable cardiac insufficiency

Outcomes

Primary Outcomes

Not specified

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