Role of Sleep in Cardiovascular Functions

NCT04166916 | Completed DMC

• 1 other identifier: 2019-01538
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Outcome Measures

Primary Outcomes (5)

• Cardiac autonomic regulation

  assessed by heart rate variability derived from electrocardiography

  continuously across approximately 8 hours of sleep with and without acoustic stimulation

• Change in cardiac autonomic regulation

  assessed by changes in heart rate variability derived from electrocardiography

  Before to after approximately 8 hours of sleep with and without acoustic stimulation

• Heart rate

  measured with electrocardiography

  continuously across approximately 8 hours of sleep with and without acoustic stimulation

• Change in heart rate

  measured with electrocardiography

  Before to after approximately 8 hours of sleep with and without acoustic stimulation

• Marker for sleep depth

  Slow wave activity assessed with high-density electroencephalography(hdEEG)

  continuously across approximately 8 hours of sleep with and without acoustic stimulation

Secondary Outcomes (9)

• Change in vascular functioning

  Before and/or after approximately 8 hours of sleep with and without acoustic stimulation

• Arterial pressure waveform

  continuously across approximately 8 hours of sleep with and without acoustic stimulation

• Change in arterial pressure waveform

  Before to after approximately 8 hours of sleep with and without acoustic stimulation

• Oxyen saturation

  continuously across approximately 8 hours of sleep with and without acoustic stimulation

• Overnight memory consolidation

  Before to after approximately 8 hours of sleep with and without acoustic stimulation

Other Outcomes (8)

• Incidence of Intervention-related Adverse Events (Safety and Tolerability)

  Through study completion approximately one month

• Chronotype

  During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit)

• Body mass index

  During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit)

Study Arms (3)

Slow waves enhancing acoustic stimulation

ACTIVE COMPARATOR

During non-rapid eye movement (NREM) sleep, acoustic stimuli will be played to increase slow wave amplitude.

Other: Acoustic stimulation

SHAM: no application of acoustic stimuli

SHAM COMPARATOR

During NREM sleep no acoustic stimuli will be played.

Other: SHAM acoustic stimulation

Slow waves decreasing acoustic stimulation

ACTIVE COMPARATOR

During NREM sleep acoustic stimuli will be played to decrease/modulate slow waves amplitude in a dose-dependent way (e.g. less pronounced than arm 1).

Other: Acoustic stimulation

Interventions

Acoustic stimulation OTHER

Acoustic stimulation to modulate slow waves.

Slow waves decreasing acoustic stimulation; Slow waves enhancing acoustic stimulation

SHAM acoustic stimulation OTHER

This is the sham-control intervention; only the biosignal will be recorded but no acoustic stimulation will be played.

SHAM: no application of acoustic stimuli

Eligibility Criteria

• Age: 18 Years - 84 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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),

Sponsors & Collaborators

• Caroline Lustenberger: lead

Study Sites (1)

ETH Zurich

Zurich, Schweiz, 8057, Switzerland

Location

Related Publications (1)

• Huwiler S, Carro-Dominguez M, Stich FM, Sala R, Aziri F, Trippel A, Ryf T, Markendorf S, Niederseer D, Bohm P, Stoll G, Laubscher L, Thevan J, Spengler CM, Gawinecka J, Osto E, Huber R, Wenderoth N, Schmied C, Lustenberger C. Auditory stimulation of sleep slow waves enhances left ventricular function in humans. Eur Heart J. 2023 Oct 21;44(40):4288-4291. doi: 10.1093/eurheartj/ehad630. No abstract available.

  PMID: 37794725 DERIVED

MeSH Terms

Interventions

Acoustic Stimulation

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Study Officials

• Caroline Lustenberger, PhD

  ETH Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: we forecast the enrollment of 70 participants which includes the conduction of pilot assessments and the collection of 18 complete participant datasets for the main clinical trial (described here).

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: November 18, 2019
• Study Start: January 13, 2020
• Primary Completion: March 11, 2021
• Study Completion: March 11, 2021
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)