Sleep Revolution - evaluation of a novel diagnostic and therapeutic pathway for patients with obstructive sleep apnea

Not Applicable

• Conditions: Sleep apnea; Nervous System Diseases

• Registration Number: ISRCTN17539031
• Lead Sponsor: Directorate-General for Research and Innovation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-02-23
• Last Update Posted: 15 April 2024
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Staff time spent for the sleep apnea diagnostic pathway – comparison between Standard Care (SC) and the Sleep Revolution (SR) model in patients with suspected obstructive sleep apnea (OSA) from patient inclusion to final consultation with the sleep physician (units: minutes)