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CompletedNCT04166916Updated May 16, 2025

Role of Sleep in Cardiovascular Functions

An interventional study of Acoustic stimulation and SHAM acoustic stimulation in Sleep, sponsored by Caroline Lustenberger. Completed at 1 site in Switzerland. Open to male participants aged 18 Years to 84 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-16.

Sponsored by Caroline Lustenberger · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years to 84 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Sleep
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In context

Lead sponsor

This is the only study on the registry with Caroline Lustenberger as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 84 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

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

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),
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
71 participants (actual)

Study arms

  • Active comparator
    Slow waves enhancing acoustic stimulation

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

    Other: Acoustic stimulation

  • Sham comparator
    SHAM: no application of acoustic stimuli

    During NREM sleep no acoustic stimuli will be played.

    Other: SHAM acoustic stimulation

  • Active comparator
    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).

    Other: Acoustic stimulation

Interventions

  • OtherAcoustic stimulation

    Acoustic stimulation to modulate slow waves.

  • OtherSHAM acoustic stimulation

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

06

What researchers measure

Primary outcomes

  1. Cardiac autonomic regulation

    assessed by heart rate variability derived from electrocardiography

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

  2. Change in cardiac autonomic regulation

    assessed by changes in heart rate variability derived from electrocardiography

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

  3. Heart rate

    measured with electrocardiography

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

  4. Change in heart rate

    measured with electrocardiography

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

  5. Marker for sleep depth

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

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

Secondary outcomes

  1. Change in vascular functioning

    Assessed by outcomes of blood profiles of vascular inflammation, pulmonal arterial pressure, intima media thickness, or echocardiography

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

  2. Arterial pressure waveform

    assessed by arterial pressure waveform measures

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

  3. Change in arterial pressure waveform

    assessed by arterial pressure waveform measures

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

  4. Oxyen saturation

    assessed by pulse oximetry

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

  5. Overnight memory consolidation

    Assessed by memory tasks

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

  6. Changes in vigilance

    assessed by simple vigilance task

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

  7. Changes in muscular fatigue

    assessed by simple muscular fatigue task

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

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

    Assessment of resting state and task-related hdEEG

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

  9. Hypnogram

    assessed by sleep staging of hdEEG data

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

Other outcomes

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

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

    Time frame: Through study completion approximately one month

  2. Chronotype

    Assessment of circadian type

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

  3. Body mass index

    Assessment of height, weight to calculate body mass index

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

  4. Hip-to-waist ratio

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

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

  5. Subjective sleep quality

    assessed by Pittsburgh Sleep quality index

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

  6. Daytime sleepiness

    assessed by Epworth sleepiness scale

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

  7. Change in sleepiness

    assessed by Karolinska Sleepiness Scale or Stanford Sleepiness Scale

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

  8. Body composition

    Assessment of body composition through DEXA scan

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

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Study locations

1 site
  • ETH Zurich
    Zurich, Schweiz 8057, Switzerland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04166916
Lead sponsor
Caroline Lustenberger
Responsible party
Caroline Lustenberger (Principal Investigator, Swiss Federal Institute of Technology) — Sponsor-investigator
First posted
Nov 18, 2019
Start date
Jan 13, 2020
Primary completion
Mar 11, 2021
Completion
Mar 11, 2021
Last update
May 16, 2025

Study contacts

Caroline Lustenberger, PhD
principal investigator · ETH Zurich

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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