Obstructive Sleep Apnea - Autonomic and Vascular Exploration

NCT05920083 | Terminated DMC

• 1 other identifier: 01012023
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

OSA; CPAP

Outcome Measures

Primary Outcomes (2)

• Change in flow-mediated dilation

  Endothelial function as measured with flow-mediated dilation

  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

  Between BRS measured after 2 weeks of CPAP withdrawal and BRS measured after 2 weeks on CPAP

Secondary Outcomes (4)

• Arterial stiffness assessed by the pulse transit time

  Baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP

• Nocturnal heart rate variability indices (linear and non linear)

  baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP

• Change in heart rate response to the cold pressure test

  baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP

• Hypoxic burden

  baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP

Study Arms (1)

CPAP withdrawal

EXPERIMENTAL

CPAP withdrawal for 2 weeks

Other: CPAP withdrawal

Interventions

CPAP withdrawal OTHER

2 weeks of CPAP withdrawal

CPAP withdrawal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Raphael Heinzer: lead

Study Sites (1)

Lausanne University Hospital

Lausanne, Canton of Vaud, 1012, Switzerland

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Raphael Heinzer, Pr.

  Centre Hospitalier Universitaire Vaudois (CHUV)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: one group, before-after design

Study Record Dates

• First Submitted: June 6, 2023
• First Posted: June 27, 2023
• Study Start: January 12, 2024
• Primary Completion: September 11, 2024
• Study Completion: September 11, 2024
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)