SleepNCT04166916

Role of Sleep in Cardiovascular Functions

A study testing Acoustic stimulation in people with Sleep, run by Caroline Lustenberger at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 84 years, men onlyHealthy volunteers can take part
Conditions the study is for: Sleep
What is being tested?: Acoustic stimulation
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 71 participants
Where: 1 siteSwitzerland
Study dates: 13 Jan 2020to 11 Mar 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 84 years
Men only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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),

Show all 19Show fewer

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),

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

ETH Zurich
Zurich, Schweiz, 8057

Other trials in Switzerland

About this study

Official title: Modulation of Sleep Slow Wave Activity Through Acoustic Stimulation and Its Consequences on 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.

Conditions: Sleep
Being tested: Acoustic stimulation, SHAM acoustic stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Acoustic stimulationOther
Acoustic stimulation to modulate slow waves.
SHAM acoustic stimulationOther
This is the sham-control intervention; only the biosignal will be recorded but no acoustic stimulation will be played.

Study groups in NCT04166916
Study group	Role	What they receive
Slow waves enhancing acoustic stimulation	Active comparator	During non-rapid eye movement (NREM) sleep, acoustic stimuli will be played to increase slow wave amplitude. Receives: Other: Acoustic stimulation
SHAM: no application of acoustic stimuli	Sham comparator	During NREM sleep no acoustic stimuli will be played. Receives: 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). Receives: Other: Acoustic stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

Cardiac autonomic regulation
assessed by heart rate variability derived from electrocardiography
Measured: 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
Measured: Before to after approximately 8 hours of sleep with and without acoustic stimulation
Heart rate
measured with electrocardiography
Measured: continuously across approximately 8 hours of sleep with and without acoustic stimulation
Change in heart rate
measured with electrocardiography
Measured: 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)
Measured: continuously across approximately 8 hours of sleep with and without acoustic stimulation

Secondary outcomes (9)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jan 202011 Mar 2021

First posted18 Nov 2019
Study start13 Jan 2020
Primary completion11 Mar 2021
Study completion11 Mar 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for SleepStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Model description: 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).
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04166916
Sponsor's protocol ID: 2019-01538
Other IDs: 2019
Status last verified: May 2025
First submitted: 18 Oct 2019
Last updated: 16 May 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Alessandrelli G, Huwiler S, Bernardi G, Carro-Dominguez M, Stich F, Sala R, Aziri F, Trippel A, Markendorf S, Niederseer D, Bohm P, Cerveri P, Siclari F, Huber R, Wenderoth N, Schmied C, Lustenberger C. Cardiovascular Responses to Natural and Auditory Evoked Slow Waves Predict Post-Sleep Cardiac Function. J Sleep Res. 2026 Jun 1:e70354. doi: 10.1111/jsr.70354. Online ahead of print.
PubMed 42220219
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.
PubMed 37794725

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Healthy Adult Participants

All Sleep trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Modulation of Sleep Slow Wave Activity Through Acoustic Stimulation and Its Consequences on Cardiovascular Functions
ClinicalTrials.gov ID: NCT04166916
Acronym / sponsor ID: 2019-01538
Conditions: Sleep
Study type: Interventional
Recruitment status: Completed
Enrolment: 71 participants (actual)
Lead sponsor: Caroline LustenbergerUniversity, hospital or other
Study start: 13 Jan 2020 (actual)
Primary completion: 11 Mar 2021 (actual)
Study completion: 11 Mar 2021 (actual)
First posted: 18 Nov 2019 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 3
Model description: 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).

Arm	Type	Receives
Slow waves enhancing acoustic stimulation	Active comparator	Other: Acoustic stimulationDuring non-rapid eye movement (NREM) sleep, acoustic stimuli will be played to increase slow wave amplitude.
SHAM: no application of acoustic stimuli	Sham comparator	Other: SHAM acoustic stimulationDuring NREM sleep no acoustic stimuli will be played.
Slow waves decreasing acoustic stimulation	Active comparator	Other: Acoustic stimulationDuring 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).

Who may qualify

Ages: 18 to 84 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (19 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Acoustic stimulationAcoustic stimulation to modulate slow waves.	Other	Slow waves decreasing acoustic stimulation, Slow waves enhancing acoustic stimulation
SHAM acoustic stimulationThis is the sham-control intervention; only the biosignal will be recorded but no acoustic stimulation will be played.	Other	SHAM: no application of acoustic stimuli

Primary outcome

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
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
Heart rate
Time frame: continuously across approximately 8 hours of sleep with and without acoustic stimulation
measured with electrocardiography
Change in heart rate
Time frame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
measured with electrocardiography
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)

9 secondary outcomes

Change in vascular functioning
Time frame: Before and/or after approximately 8 hours of sleep with and without acoustic stimulation
Arterial pressure waveform
Time frame: continuously across approximately 8 hours of sleep with and without acoustic stimulation
Change in arterial pressure waveform
Time frame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
Oxyen saturation
Time frame: continuously across approximately 8 hours of sleep with and without acoustic stimulation
Overnight memory consolidation
Time frame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
Changes in vigilance
Time frame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
Changes in muscular fatigue
Time frame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
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
Hypnogram
Time frame: Over approximately 8 hours of sleep with and without acoustic stimulation

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
Derived from this study: PubMed 42220219Alessandrelli G, Huwiler S, Bernardi G, Carro-Dominguez M, Stich F, Sala R, Aziri F, Trippel A, Markendorf S, Niederseer D, Bohm P, Cerveri P, Siclari F, Huber R, Wenderoth N, Schmied C, Lustenberger C. Cardiovascular Responses to Natural and Auditory Evoked Slow Waves Predict Post-Sleep Cardiac Function. J Sleep Res. 2026 Jun 1:e70354. doi: 10.1111/jsr.70354. Online ahead of print.
Derived from this study: PubMed 37794725Huwiler 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.
Individual participant dataSharing planned: No

Related trials for Sleep

Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Caroline Lustenberger, PhD principal investigator

ETH Zurich

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Acoustic stimulation in people with Sleep, run by Caroline Lustenberger at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac autonomic regulation (time frame: continuously across approximately 8 hours of sleep with and without acoustic stimulation). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04166916, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.