ACTRN12616000903482
Not yet recruiting
Phase 3
The Obstructive Sleep apnoea Intervention in AF (OSI-AF) randomised trial: Obstructive sleep apnoea treatment to reduce atrial fibrillation burden and morbidity
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Atrial Fibrillation
- Sponsor
- niversity of Sydney
- Enrollment
- 200
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Males and females with a history of paroxysmal (at least 2 prior attacks) or persistent AF (\<12 months duration \[in sinus rhythm at study entry]);
- •2\) Age 18\-75;
- •3\) Polysomnography diagnosed OSA of at least moderate severity (AHI \>\=15\);
- •4\) Ability to provide informed consent.
Exclusion Criteria
- •1\) Severe OSA related hypoxemia (\>10% sleep time with oxygen saturation \<80%) and/or awake oxygen saturation less than 92%%
- •2\) Severe respiratory disease (eg Chronic Obstructive Pulmonary Disease or (COPD)
- •3\) Current or prior mechanical treatment for OSA with CPAP or MAS
- •4\) \>50% of apnoeas and/or hyponeas associated with Cheyne\-Stokes Respiration (CSR) or Central Sleep Apnoea (CSA)
- •5\) Increased risk of sleep\-related accident and / or excessive sleepiness defined by any of:
- •\* Severe sleepiness as defined by Epworth Sleepiness Scale (\>15\)
- •\*Driver occupation (eg taxi, courier or truck driver)
- •\*Sleepiness\-related motor vehicle accident, or near accident, within last 12 months prior to enrolment
- •6\) Any relative or absolute contra\-indication to CPAP or MAS therapy including chronic cranial injury; recurrent pneumothorax; indication for oral\-pharyngeal surgery, edentulous, or loose teeth
- •7\) Any severe other cardiac disease likely to impact ability to comply:
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Not Applicable
Assessment and management of obstructive sleep apnoea following bariatric surgeryACTRN12617000199314Christopher Wong200
Recruiting
Not Applicable
Diagnosis and treatment of obstructive sleep apnoea in patients with head and neck squamous cell carcinoma treated primary chemo/radiation therapyG47.3C13C14Sleep apnoeaMalignant neoplasm of hypopharynxMalignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynxDRKS00021731niversitätsmedizin Mainz220
Recruiting
Not Applicable
Diagnosis and treatment of obstructive sleep apnoea in patients with head and neck squamous cell carcinoma treated with surgery and adjuvant radiation therapyG47.3C14C13Sleep apnoeaMalignant neoplasm of other and ill-defined sites in the lip, oral cavity and pharynxMalignant neoplasm of hypopharynxDRKS00021692niversitätsmedizin Mainz220
Completed
Not Applicable
Management of the obstructive sleep apnea-hypopnea syndrome: oral appliance versus continuous positive airway pressure therapyObstructive Sleep Apnea-Hypopnea Syndrome (OSAHS)Nervous System DiseasesSleep disordersISRCTN18174167niversity Medical Center Groningen (The Netherlands)102
Recruiting
Not Applicable
Treatment of severe obstructive sleep apnea syndrome: evaluation of a therapy combining continuous positive airway pressure with an oral appliance: a pilot study'obstructive sleep apnea syndrome' and 'sleep apnea'10046304NL-OMON34972niversitair Medisch Centrum Groningen10