Obstructive Sleep Apnea - Autonomic and Vascular Exploration

Not Applicable

Recruiting

• Conditions: Obstructive Sleep Apnea
• Interventions: Other: CPAP withdrawal

• Registration Number: NCT05920083
• Lead Sponsor: Raphael Heinzer

Brief Summary

The goal of this clinical trial is to assess the effect of CPAP withdrawal on vascular and autonomic function in patients with obstructive sleep apnea. The main question it aims to answer is:

• Is the pulse wave amplitude index able to predict the impact of sleep apnea treatment withdrawal (continuous positive airway pressure, CPAP) on endothelial function and baroreflex sensitivity?

Participants will stop using their CPAP for 2 weeks and the investigators will assess vascular and autonomic function before and after the withdrawal. Researchers will compare endothelial and autonomic function at baseline and after 2 weeks of withdrawal to see if there are differences. Moreover, they will assess the association between pulse wave amplitude drop profile and effect of CPAP withdrawal.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-15
• Study First Posted: 2023-06-27
• Status Verified: 2024-01
• Study Start: 2024-01
• Last Update Submitted: 2024-01-10
• Last Update Posted: 2024-01-12
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Age ≥18 years old
• Diagnosed with OSA (AHI ≥15 events/h), confirmed during screening period
• Adequately treated with CPAP therapy for ≥6 months
• Able to give informed consent as documented by signature

Exclusion Criteria

• Professional drivers will be excluded from the study because temporary withdrawal of CPAP may induce drowsiness.

• We will also exclude patients with conditions that may affect endothelial and autonomic function:

  • Known Diabetes
  • Known heart failure
  • Known chronic kidney disease
  • Pregnant or lactating women
  • Morbid obesity (≥40 kg/m2)
  • Known Excessive alcohol consumption
  • Known Dementia (especially dementia with Lewy bodies). (61)
  • Patients using alpha and beta blockers
  • Known atrial fibrillation
  • Inability to follow the procedures of the study due to language problems or psychological disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CPAP withdrawal	CPAP withdrawal	CPAP withdrawal for 2 weeks

Primary Outcome Measures

Name	Time	Method
Change in flow-mediated dilation	Between FMD measured after 2 weeks of CPAP withdrawal and FMD measured after 2 weeks on CPAP	Endothelial function as measured with flow-mediated dilation
Change in the slope of baroreflex sensitivity	Between BRS measured after 2 weeks of CPAP withdrawal and BRS measured after 2 weeks on CPAP	Autonomic function as measure with the slope of BRS

Secondary Outcome Measures

Name	Time	Method
Change in heart rate response to the cold pressure test	baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP	delta heart rate before and after cold pressure test
Nocturnal heart rate variability indices (linear and non linear)	baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP	HRV measured on the ECG of polygraphy
Hypoxic burden	baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP	hypoxic burden of sleep apnea based on polysomnography
Arterial stiffness assessed by the pulse transit time	Baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP	arterial stiffness measured by the pulse transit time

Trial Locations

Locations (1)

Lausanne University Hospital; 🇨🇭 Lausanne, Vaud, Switzerland