ISRCTN17539031
Active, not recruiting
未知
A randomized cross over trial exploring the Sleep Revolution diagnostic and therapeutic pathway in patients with obstructive sleep apnea
Directorate-General for Research and Innovation0 sites1,000 target enrollmentFebruary 23, 2024
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Sleep apnea
- Sponsor
- Directorate-General for Research and Innovation
- Enrollment
- 1000
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Main Inclusion Criteria:
- •1\. Referral to the sleep center due to suspected obstructive sleep apnea as the main question for evaluation
- •2\. Male or female aged 18 years and above
- •3\. Willing and able to provide written informed consent
- •4\. Willing and able to comply with the study design schedule and other requirements (e.g. no long\-term travel conflicting with the planned visits throughout the study)
Exclusion Criteria
- •Main Exclusion Criteria:
- •1\. Any ongoing treatment for OSA or central sleep apnea (CSA)
- •2\. Known significant hypercapnic respiratory failure due to chronic obstructive pulmonary disease or other respiratory condition
- •3\. Any other clinically determined contraindication for PAP treatment
- •4\. Patients participating in any type of weight loss treatment program
- •5\. Unstable congestive heart failure or angina pectoris
- •6\. Any other condition – to the judgement of the investigator – which potentially may jeopardize the completion of the study according to protocol
- •7\. History of alcohol or drug abuse during the last year, substance use disorder at screening
Outcomes
Primary Outcomes
Not specified
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