OSAVE: Obstructive Sleep Apnea - Autonomic and Vascular Exploration

• Sponsor: Raphael Heinzer (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05920083
• Collaborator: (none)
• Enrollment: 65
• Arm: 1
• Anticipated Duration (Months): 16

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstructive Sleep Apnea	Other: CPAP withdrawal	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: one group, before-after designone group, before-after design
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Noctural Pulse Waves Variations in OSA as a Predictor of Autonomic and Vascular Response to CPAP Therapy
• Anticipated Study Start Date: Aug 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CPAP withdrawal CPAP withdrawal for 2 weeks	Other: CPAP withdrawal; 2 weeks of CPAP withdrawal

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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

2. 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

3. 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

4. Hypoxic burden [baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP]

   hypoxic burden of sleep apnea based on polysomnography

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Raphael Heinzer

Investigators

• Principal Investigator: Raphael Heinzer, Pr., Centre Hospitalier Universitaire Vaudois (CHUV)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Raphael Heinzer, Professor, University of Lausanne Hospitals
• ClinicalTrials.gov Identifier: NCT05920083
• Other Study ID Numbers: 01012023
• First Posted: Jun 27, 2023
• Last Update Posted: Jun 27, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Raphael Heinzer, Professor, University of Lausanne Hospitals: OSA; CPAP
• Additional relevant MeSH terms: Sleep Apnea Syndromes; Sleep Apnea, Obstructive

Study Results

No Results Posted as of Jun 27, 2023