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Completed

NCT Number: NCT04166916

Role of Sleep in Cardiovascular Functions

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.

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Key information

Conditions

Sleep

Age range

18 year–84 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

ETH Zurich

Zurich, Schweiz, 8057, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

Acoustic stimulation

Other

Acoustic stimulation to modulate slow waves.

Sham acoustic stimulation

Other

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

Primary outcomes

  1. Cardiac autonomic regulation

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

    assessed by heart rate variability derived from electrocardiography

  2. Change in cardiac autonomic regulation

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

    assessed by changes in heart rate variability derived from electrocardiography

  3. Heart rate

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

    measured with electrocardiography

  4. Change in heart rate

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

    measured with electrocardiography

  5. Marker for sleep depth

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

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

Secondary outcomes

  1. Change in vascular functioning

    Time frame: 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

  2. Arterial pressure waveform

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

    assessed by arterial pressure waveform measures

  3. Change in arterial pressure waveform

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

    assessed by arterial pressure waveform measures

  4. Oxyen saturation

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

    assessed by pulse oximetry

  5. Overnight memory consolidation

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

    Assessed by memory tasks

  6. Changes in vigilance

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

    assessed by simple vigilance task

  7. Changes in muscular fatigue

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

    assessed by simple muscular fatigue task

  8. Changes in bandwidth of of 0.5-30 Hz of high-density electroencephalography (hdEEG)

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

    Assessment of resting state and task-related hdEEG

  9. Hypnogram

    Time frame: Over approximately 8 hours of sleep with and without acoustic stimulation

    assessed by sleep staging of hdEEG data

Other outcomes

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

    Time frame: Through study completion approximately one month

    Any adverse or serious adverse event during the study period will be assessed

  2. Chronotype

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

    Assessment of circadian type

  3. Body mass index

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

    Assessment of height, weight to calculate body mass index

  4. Hip-to-waist ratio

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

    Assessment of hip and waist circumference to calculate hip-to-waist ratio

  5. Subjective sleep quality

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

    assessed by Pittsburgh Sleep quality index

  6. Daytime sleepiness

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

    assessed by Epworth sleepiness scale

  7. Change in sleepiness

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

    assessed by Karolinska Sleepiness Scale or Stanford Sleepiness Scale

  8. Body composition

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

    Assessment of body composition through DEXA scan

Sponsors and collaborators

Lead sponsor

Caroline Lustenberger

Other

Registry information

Official study title

Modulation of Sleep Slow Wave Activity Through Acoustic Stimulation and Its Consequences on Cardiovascular Functions

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 18, 2019
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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