Status:
COMPLETED
AutoSet for Her Clinical Trial Protocol
Lead Sponsor:
ResMed
Collaborating Sponsors:
The University of Western Australia
Conditions:
Obstructive Sleep Apnea
Eligibility:
FEMALE
18-50 years
Phase:
NA
Brief Summary
The purpose of this study is to assess the efficacy and user preference of the Newport AutoSet for Her in female obstructive sleep apnea (OSA) patients. Efficacy will be evaluated by comparing the ap...
Eligibility Criteria
Inclusion
- Pre-menopausal females aged ≥ 18 years
- Current positive airway pressure (PAP)(CPAP or APAP) therapy user with 'current' defined as on PAP therapy for at least 1 month prior to study entry
- Diagnostic PSG available
- Diagnosis of mild-moderate OSA (AHI ≤ 30)
- Participants willing and able to give written informed consent
Exclusion
- Participants currently using Bi-level PAP
- Participants currently using supplemental oxygen
- Participants who are pregnant
- Subjects who have a pre existing lung disease/ condition that would predispose them to pneumothorax (for example: COPD, lung cancer; fibrosis of the lungs; recent (\< 2years) case of pneumonia or lung infection; lung injury)
- Participants who the researcher believes are unsuitable for inclusion because either:
- they do not comprehend English
- they are unable to provide written informed consent
- they are physically unable to comply with the protocol
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01826513
Start Date
May 1 2013
End Date
June 1 2013
Last Update
March 27 2017
Active Locations (1)
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1
West Australian Sleep Disorders Research Institute
Nedlands, Western Australia, Australia, 6009