Role of Sleep in Cardiovascular Functions

NCT ID: NCT04166916

Last Updated: 2025-05-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-13
• Study Completion Date: 2021-03-11

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Slow waves enhancing acoustic stimulation

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

Group Type: ACTIVE_COMPARATOR

Acoustic stimulation

Intervention Type: OTHER

Acoustic stimulation to modulate slow waves.

SHAM: no application of acoustic stimuli

During NREM sleep no acoustic stimuli will be played.

Group Type: SHAM_COMPARATOR

SHAM acoustic stimulation

Intervention Type: OTHER

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

Slow waves decreasing acoustic stimulation

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).

Group Type: ACTIVE_COMPARATOR

Acoustic stimulation

Intervention Type: OTHER

Acoustic stimulation to modulate slow waves.

Interventions

Acoustic stimulation

Acoustic stimulation to modulate slow waves.

Intervention Type: OTHER

SHAM acoustic stimulation

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

Intervention Type: OTHER

Eligibility Criteria

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),

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Caroline Lustenberger

OTHER

Sponsor Role: lead

Responsible Party

Caroline Lustenberger

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Caroline Lustenberger, PhD

Role: PRINCIPAL_INVESTIGATOR

ETH Zurich

Locations

ETH Zurich

Zurich, Schweiz, Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 37794725 (View on PubMed)

Other Identifiers

2019-01538

Identifier Type: -

Identifier Source: org_study_id