Obstructive Sleep Apnea - Autonomic and Vascular Exploration | NCT05920083

Studies
Obstructive Sleep Apnea - Autonomic and Vascular Exploration

NCT05920083

Sponsor

Raphael Heinzer

Status

Terminated

Last Update Posted

Dec 12, 2025Actual

Enrollment

65Actual

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea

Interventions

CPAP withdrawal

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty recruiting desired number of participant.

Expanded Access Info

Start Date

Jan 12, 2024Actual

Primary Completion Date

Sep 11, 2024Actual

Completion Date

Sep 11, 2024Actual

First Submitted Date

Jun 6, 2023

First Submission Date that Met QC Criteria

Jun 15, 2023

First Posted Date

Jun 27, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2025

Last Update Posted Date

Dec 12, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CPAP withdrawal	Experimental	CPAP withdrawal for 2 weeks	Other: CPAP withdrawal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CPAP withdrawal	Other	2 weeks of CPAP withdrawal	CPAP withdrawal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Arterial stiffness assessed by the pulse transit time	arterial stiffness measured 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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Raphael Heinzer, Pr.	Centre Hospitalier Universitaire Vaudois (CHUV)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lausanne University Hospital		Lausanne	Canton of Vaud	1012	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

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Browse Branches

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