Obstructive Sleep Apnea - Autonomic and Vascular Exploration (OSAVE)

Raphael Heinzer

Status

Terminated

Conditions

Obstructive Sleep Apnea

Treatments

Other: CPAP withdrawal

Study type

Interventional

Funder types

Other

Identifiers

NCT05920083

01012023

Details and patient eligibility

About

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.

Enrollment

65 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.