Status:
COMPLETED
REMStar Auto With C-Flex - In-Laboratory Performance v. Conventionally Titrated CPAP Therapy: Performances and Preferences
Lead Sponsor:
University of British Columbia
Conditions:
Obstructive Sleep Apnoea Hypopnoea Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the use of REMStar Auto with C-Flex (RSA C-Flex) therapy in subjects with previously diagnosed obstructive sleep apnea / hypopnea syndrome, during in-laboratory studies. The s...
Detailed Description
The research question we are exploring is whether the To determine if treatment with C-FLEX is at least equivalent to conventional CPAP therapy as evidenced by standard sleep and breathing variables a...
Eligibility Criteria
Inclusion
- Age ≥ 18
- Primary medical diagnosis Obstructive Sleep Apnea / Hypopnea Syndrome
- AHI ≥ 15 events•hr-1 of sleep
- Ability to provide consent
- Successful completion of a conventional CPAP titration in a sleep laboratory under polysomnographic conditions (success defined by reduction of AHI to \< 5•hr-1 during therapeutic portion of study, in supine position and in REM and NREM sleep state).
Exclusion
- Patients who are medically complicated or who are medically unstable.
- Patients who have been on chronic CPAP or BiPAP therapy or require oxygen therapy.
- Patients with respiratory failure or respiratory insufficiency or who have elevated arterial carbon dioxide levels while awake.
- Patients who have had surgery of the upper airway, nose, sinus, or middle ear within the previous 90 days.
- Patients with non-OSA sleep disorders.
- Patients in whom PAP therapy is otherwise medically contraindicated.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00358800
Start Date
February 1 2005
End Date
December 1 2005
Last Update
August 1 2006
Active Locations (1)
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1
UBC Sleep Disorder Program and Sleep Lab, UBC Hospital
Vancouver, British Columbia, Canada