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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Slow waves enhancing acoustic stimulation | Active Comparator | During non-rapid eye movement (NREM) sleep, acoustic stimuli will be played to increase slow wave amplitude. |
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| SHAM: no application of acoustic stimuli | Sham Comparator | During NREM sleep no acoustic stimuli will be played. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acoustic stimulation | Other | Acoustic stimulation to modulate slow waves. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in vascular functioning | Assessed by outcomes of blood profiles of vascular inflammation, pulmonal arterial pressure, intima media thickness, or echocardiography | Before and/or after approximately 8 hours of sleep with and without acoustic stimulation |
| Arterial pressure waveform |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Intervention-related Adverse Events (Safety and Tolerability) | Any adverse or serious adverse event during the study period will be assessed | Through study completion approximately one month |
| Chronotype |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Caroline Lustenberger, PhD | ETH Zurich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ETH Zurich | Zurich | Schweiz | 8057 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42220219 | Derived | 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. | |
| 37794725 |
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| ID | Term |
|---|---|
| D000161 | Acoustic Stimulation |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D026421 | Sensory Art Therapies |
| D000529 | Complementary Therapies |
| D010812 | Physical Stimulation |
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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).
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| SHAM acoustic stimulation | Other | This is the sham-control intervention; only the biosignal will be recorded but no acoustic stimulation will be played. |
|
assessed by arterial pressure waveform measures |
| continuously across approximately 8 hours of sleep with and without acoustic stimulation |
| Change in arterial pressure waveform | assessed by arterial pressure waveform measures | Before to after approximately 8 hours of sleep with and without acoustic stimulation |
| Oxyen saturation | assessed by pulse oximetry | continuously across approximately 8 hours of sleep with and without acoustic stimulation |
| Overnight memory consolidation | Assessed by memory tasks | Before to after approximately 8 hours of sleep with and without acoustic stimulation |
| Changes in vigilance | assessed by simple vigilance task | Before to after approximately 8 hours of sleep with and without acoustic stimulation |
| Changes in muscular fatigue | assessed by simple muscular fatigue task | 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 | Before to after approximately 8 hours of sleep with and without acoustic stimulation |
| Hypnogram | assessed by sleep staging of hdEEG data | Over approximately 8 hours of sleep with and without acoustic stimulation |
Assessment of circadian type
| During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit) |
| Body mass index | Assessment of height, weight to calculate body mass index | During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit) |
| Hip-to-waist ratio | Assessment of hip and waist circumference to calculate hip-to-waist ratio | During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit) |
| Subjective sleep quality | assessed by Pittsburgh Sleep quality index | During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit) |
| Daytime sleepiness | assessed by Epworth sleepiness scale | During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit) |
| Change in sleepiness | assessed by Karolinska Sleepiness Scale or Stanford Sleepiness Scale | Before to after approximately 8 hours of sleep with and without acoustic stimulation |
| Body composition | Assessment of body composition through DEXA scan | During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit) |
| Derived |
| 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. |
| D008919 |
| Investigative Techniques |