Obstructive Sleep Apnea - Autonomic and Vascular Exploration

Obstructive Sleep Apnea Clinical Trial

— OSAVE  

Official title:

Noctural Pulse Waves Variations in OSA as a Predictor of Autonomic and Vascular Response to CPAP Therapy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05920083
• Other study ID #: 01012023
• Status: Recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: University of Lausanne Hospitals
• Contact: Adrien Waeber, physician
• Phone: 0041795850028
• Email: adrien.waeber[@]chuv.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• CPAP withdrawal
2 weeks of CPAP withdrawal

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital	Lausanne	Vaud

Sponsors (1)

Lead Sponsor	Collaborator
Raphael Heinzer

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Nocturnal heart rate variability indices (linear and non linear)	HRV measured on the ECG of polygraphy	baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Secondary	Change in heart rate response to the cold pressure test	delta heart rate before and after cold pressure test	baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP
Secondary	Hypoxic burden	hypoxic burden of sleep apnea based on polysomnography	baseline, after 2 weeks of withdrawal, after 2 weeks on CPAP