Clinical trial NCT05920083: Obstructive Sleep Apnea - Autonomic and Vascular Exploration
Official title: Noctural Pulse Waves Variations in OSA as a Predictor of Autonomic and Vascular Response to CPAP Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: OSA
CPAP
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: one group, before-after design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in flow-mediated dilation
timeFrame: Between FMD measured after 2 weeks of CPAP withdrawal and FMD measured after 2 weeks on CPAP
measure: Change in the slope of baroreflex sensitivity
timeFrame: Between BRS measured after 2 weeks of CPAP withdrawal and BRS measured after 2 weeks on CPAP
Secondary outcomes:
measure: Arterial stiffness assessed by the pulse transit time
timeFrame: Baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
measure: Nocturnal heart rate variability indices (linear and non linear)
timeFrame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
measure: Change in heart rate response to the cold pressure test
timeFrame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
measure: Hypoxic burden
timeFrame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Lausanne University Hospital
state: Vaud
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois (CHUV)
name: Raphael Heinzer, Pr.
role: PRINCIPAL_INVESTIGATOR
References: