Obstructive Sleep Apnea - Autonomic and Vascular Exploration

N/ATerminatedNCT05920083

Raphael Heinzer65 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Change in flow-mediated dilation

Endothelial function as measured with flow-mediated dilation

Time frame: Between FMD measured after 2 weeks of CPAP withdrawal and FMD measured after 2 weeks on CPAP

Change in the slope of baroreflex sensitivity

Autonomic function as measure with the slope of BRS

Time frame: Between BRS measured after 2 weeks of CPAP withdrawal and BRS measured after 2 weeks on CPAP

Secondary Outcomes

Arterial stiffness assessed by the pulse transit time

arterial stiffness measured by the pulse transit time

Time frame: Baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP

Nocturnal heart rate variability indices (linear and non linear)

HRV measured on the ECG of polygraphy

Time frame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP

Change in heart rate response to the cold pressure test

delta heart rate before and after cold pressure test

Time frame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP

Hypoxic burden

hypoxic burden of sleep apnea based on polysomnography

Time frame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP

Obstructive Sleep Apnea - Autonomic and Vascular Exploration

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes