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Obstructive Sleep Apnea - Autonomic and Vascular Exploration (OSAVE)

Primary Purpose

Obstructive Sleep Apnea

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPAP withdrawal
Sponsored by
Raphael Heinzer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring OSA, CPAP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    CPAP withdrawal

    Arm Description

    CPAP withdrawal for 2 weeks

    Outcomes

    Primary Outcome Measures

    Change in flow-mediated dilation
    Endothelial function as measured with flow-mediated dilation
    Change in the slope of baroreflex sensitivity
    Autonomic function as measure with the slope of BRS

    Secondary Outcome Measures

    Arterial stiffness assessed by the pulse transit time
    arterial stiffness measured by the pulse transit time
    Nocturnal heart rate variability indices (linear and non linear)
    HRV measured on the ECG of polygraphy
    Change in heart rate response to the cold pressure test
    delta heart rate before and after cold pressure test
    Hypoxic burden
    hypoxic burden of sleep apnea based on polysomnography

    Full Information

    First Posted
    June 6, 2023
    Last Updated
    September 21, 2023
    Sponsor
    Raphael Heinzer
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05920083
    Brief Title
    Obstructive Sleep Apnea - Autonomic and Vascular Exploration
    Acronym
    OSAVE
    Official Title
    Noctural Pulse Waves Variations in OSA as a Predictor of Autonomic and Vascular Response to CPAP Therapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 2023 (Anticipated)
    Primary Completion Date
    December 2024 (Anticipated)
    Study Completion Date
    December 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Raphael Heinzer

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea
    Keywords
    OSA, CPAP

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    one group, before-after design
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    65 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    CPAP withdrawal
    Arm Type
    Experimental
    Arm Description
    CPAP withdrawal for 2 weeks
    Intervention Type
    Other
    Intervention Name(s)
    CPAP withdrawal
    Intervention Description
    2 weeks of CPAP withdrawal
    Primary Outcome Measure Information:
    Title
    Change in flow-mediated dilation
    Description
    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
    Title
    Change in the slope of baroreflex sensitivity
    Description
    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 Outcome Measure Information:
    Title
    Arterial stiffness assessed by the pulse transit time
    Description
    arterial stiffness measured by the pulse transit time
    Time Frame
    Baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
    Title
    Nocturnal heart rate variability indices (linear and non linear)
    Description
    HRV measured on the ECG of polygraphy
    Time Frame
    baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
    Title
    Change in heart rate response to the cold pressure test
    Description
    delta heart rate before and after cold pressure test
    Time Frame
    baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
    Title
    Hypoxic burden
    Description
    hypoxic burden of sleep apnea based on polysomnography
    Time Frame
    baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Adrien Waeber, physician
    Phone
    0041795850028
    Email
    adrien.waeber@chuv.ch
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Raphael Heinzer, Pr.
    Organizational Affiliation
    Centre Hospitalier Universitaire Vaudois (CHUV)
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Obstructive Sleep Apnea - Autonomic and Vascular Exploration

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