Obstructive Sleep Apnea - Autonomic and Vascular Exploration (OSAVE)

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

Tracking Information

• First Submitted Date: June 6, 2023
• First Posted Date: June 27, 2023
• Last Update Posted Date: January 12, 2024
• Estimated Study Start Date: January 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: June 15, 2023)

• 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
• 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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 15, 2023)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

one group, before-after design

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Obstructive Sleep Apnea

Intervention

Other: CPAP withdrawal

2 weeks of CPAP withdrawal

Study Arms

Experimental: CPAP withdrawal

CPAP withdrawal for 2 weeks

Intervention: Other: CPAP withdrawal

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: June 15, 2023): 65
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2024
• Estimated Primary Completion Date: December 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT05920083
• Other Study ID Numbers: 01012023
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Raphael Heinzer, University of Lausanne Hospitals
• Original Responsible Party: Same as current
• Current Study Sponsor: Raphael Heinzer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Lausanne Hospitals
• Verification Date: January 2024