Role of Sleep in Cardiovascular Functions

Not Applicable

Completed

• Conditions: Sleep

• Registration Number: NCT04166916
• Lead Sponsor: Caroline Lustenberger

Brief Summary

Sleep and particularly deep sleep are playing an important role for brain and body health. Poor sleep has been associated with risk factors for cardiovascular disease and moreover, is hypothesized to increased mortality risk of cardiovascular diseases. Yet, the role of specific sleep processes for cardiovascular function remains unclear. Particularly deep sleep, which is manifested by large amplitude, low frequency oscillations is of importance for the restorative functions of sleep. Thus, the modulation of deep sleep by auditory stimulation will be of central interests to assess the cause-effect relationship of specific processes within sleep for cardiovascular regulation.

This study will assess the effects of slow wave modulating auditory stimulation on cardiovasuclar functions in healthy male participants.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-18
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-18
• Study Start: 2020-01-13
• Primary Completion: 2021-03-11
• Study Completion: 2021-03-11
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-13
• Last Update Posted: 2025-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 71

Inclusion Criteria

• Informed Consent
• Good general health status
• Male subjects 18-84 years of age
• Native German speaker or good understanding of German

Exclusion Criteria

• Contraindications on ethical grounds,
• Known or suspected non-compliance, drug or alcohol abuse,
• Regular medication intake that could pronouncedly affect outcomes of interest (e.g. beta-blocker)
• Long (> 9.5 hours per night) or short sleepers (< 6.5 hours per night),
• Smoking (regular smoker, >10 days per year, smoking not allowed during study participation)
• Participation in another study with investigational drug/therapy/interventions within the 30 days preceding and during the present study (start date adapted accordingly),
• Diseases or lesions of the nervous system (acute or residual included neurological and psychiatric diseases),
• Clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
• Pacemaker,
• Intake of on-label sleep medication,
• Presence or suspicion of sleep disorders (e.g., insomnia, sleep disordered breathing (apnea), restless legs syndrome). Possibility of apnea might be assessed in the screening night,
• Body Mass Index < 18 or > 30 kg/m2,
• Irregular sleep-wake rhythm (e.g. shift working),
• Bad sleep quality during screening night (e.g. < 75% sleep efficiency in screening night)
• Significant sleep complaints in general or excessive daytime sleepiness (PSQI > 5; ESS ≥ 11),
• Travelling more than 2 time zones in the 2 weeks before experimental session starts or during intervention (start of experiment will be adapted to fit with this criteria),
• Hearing disability/ hearing aid (only an exclusion if in a simple audiometry participants cannot hear intervention tone sound levels),
• Skin disorders/problems/allergies (face region) that will significantly worsen with electrode application,
• High caffeine consumption (> 5 servings/day; including coffee and caffeinated energy drinks),

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Cardiac autonomic regulation	continuously across approximately 8 hours of sleep with and without acoustic stimulation	assessed by heart rate variability derived from electrocardiography
Change in cardiac autonomic regulation	Before to after approximately 8 hours of sleep with and without acoustic stimulation	assessed by changes in heart rate variability derived from electrocardiography
Heart rate	continuously across approximately 8 hours of sleep with and without acoustic stimulation	measured with electrocardiography
Change in heart rate	Before to after approximately 8 hours of sleep with and without acoustic stimulation	measured with electrocardiography
Marker for sleep depth	continuously across approximately 8 hours of sleep with and without acoustic stimulation	Slow wave activity assessed with high-density electroencephalography(hdEEG)

Secondary Outcome Measures

Name	Time	Method
Change in vascular functioning	Before and/or after approximately 8 hours of sleep with and without acoustic stimulation	Assessed by outcomes of blood profiles of vascular inflammation, pulmonal arterial pressure, intima media thickness, or echocardiography
Arterial pressure waveform	continuously across approximately 8 hours of sleep with and without acoustic stimulation	assessed by arterial pressure waveform measures
Change in arterial pressure waveform	Before to after approximately 8 hours of sleep with and without acoustic stimulation	assessed by arterial pressure waveform measures
Oxyen saturation	continuously across approximately 8 hours of sleep with and without acoustic stimulation	assessed by pulse oximetry
Overnight memory consolidation	Before to after approximately 8 hours of sleep with and without acoustic stimulation	Assessed by memory tasks
Changes in vigilance	Before to after approximately 8 hours of sleep with and without acoustic stimulation	assessed by simple vigilance task
Changes in muscular fatigue	Before to after approximately 8 hours of sleep with and without acoustic stimulation	assessed by simple muscular fatigue task
Changes in bandwidth of of 0.5-30 Hz of high-density electroencephalography (hdEEG)	Before to after approximately 8 hours of sleep with and without acoustic stimulation	Assessment of resting state and task-related hdEEG
Hypnogram	Over approximately 8 hours of sleep with and without acoustic stimulation	assessed by sleep staging of hdEEG data

Trial Locations

Locations (1)

ETH Zurich; 🇨🇭 Zurich, Schweiz, Switzerland