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Clinical Trials/ISRCTN17539031
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.

Registry
who.int
Start Date
February 23, 2024
End Date
February 28, 2025
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Directorate-General for Research and Innovation

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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