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Obstructive Sleep Apnea - Autonomic and Vascular Exploration (OSAVE)

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ClinicalTrials.gov Identifier: NCT05920083
Recruitment Status : Recruiting
First Posted : June 27, 2023
Last Update Posted : January 12, 2024
Sponsor:
Information provided by (Responsible Party):
Raphael Heinzer, University of Lausanne Hospitals

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: one 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
Estimated Study Start Date : January 2024
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Apnea

Arms and Interventions
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Arm Intervention/treatment
Experimental: CPAP withdrawal
CPAP withdrawal for 2 weeks
 Other: CPAP withdrawal
2 weeks of CPAP withdrawal


Outcome Measures
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Primary Outcome Measures :
  1. Change in flow-mediated dilation [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP ]
    delta heart rate before and after cold pressure test

  4. Hypoxic burden [ Time Frame: baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP ]
    hypoxic burden of sleep apnea based on polysomnography


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05920083


Contacts
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Contact: Adrien Waeber, physician 0041795850028 adrien.waeber@chuv.ch

Locations
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Switzerland
Lausanne University Hospital Recruiting
Lausanne, Vaud, Switzerland, 1012
Contact: Adrien Waeber    0041795850028    adrien.waeber@chuv.ch   
Sponsors and Collaborators
Raphael Heinzer
Investigators
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Principal Investigator: Raphael Heinzer, Pr. Centre Hospitalier Universitaire Vaudois (CHUV)
More Information
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Responsible Party: Raphael Heinzer, Professor, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT05920083    
Other Study ID Numbers: 01012023
First Posted: June 27, 2023    Key Record Dates
Last Update Posted: January 12, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Raphael Heinzer, University of Lausanne Hospitals:
OSA
CPAP
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Respiration Disorders
Respiratory Tract Diseases
 Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases