Sleep
Conditions
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.
Interventions
OTHERAcoustic stimulation
Acoustic stimulation to modulate slow waves.
This is the sham-control intervention; only the biosignal will be recorded but no acoustic stimulation will be played.
Sponsors
Caroline Lustenberger
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention 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).
Eligibility
Sex/Gender
MALE
Age
18 Years to 84 Years
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
* 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),
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart rate | continuously across approximately 8 hours of sleep with and without acoustic stimulation | measured with electrocardiography |
| Marker for sleep depth | continuously across approximately 8 hours of sleep with and without acoustic stimulation | Slow wave activity assessed with high-density electroencephalography(hdEEG) |
| Change in heart rate | Before to after approximately 8 hours of sleep with and without acoustic stimulation | measured with electrocardiography |
| Change in cardiac autonomic regulation | Before to after approximately 8 hours of sleep with and without acoustic stimulation | assessed by changes in heart rate variability derived from electrocardiography |
| Cardiac autonomic regulation | continuously across approximately 8 hours of sleep with and without acoustic stimulation | assessed by heart rate variability derived from electrocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxyen saturation | continuously across approximately 8 hours of sleep with and without acoustic stimulation | assessed by pulse oximetry |
| Change in vascular functioning | 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 |
| Arterial pressure waveform | continuously across approximately 8 hours of sleep with and without acoustic stimulation | assessed by arterial pressure waveform measures |
| Change in arterial pressure waveform | Before to after approximately 8 hours of sleep with and without acoustic stimulation | assessed by arterial pressure waveform measures |
| Overnight memory consolidation | Before to after approximately 8 hours of sleep with and without acoustic stimulation | Assessed by memory tasks |
| Changes in vigilance | Before to after approximately 8 hours of sleep with and without acoustic stimulation | assessed by simple vigilance task |
| Changes in muscular fatigue | Before to after approximately 8 hours of sleep with and without acoustic stimulation | assessed by simple muscular fatigue task |
| Changes in bandwidth of of 0.5-30 Hz of high-density electroencephalography (hdEEG) | Before to after approximately 8 hours of sleep with and without acoustic stimulation | Assessment of resting state and task-related hdEEG |
| Hypnogram | Over approximately 8 hours of sleep with and without acoustic stimulation | assessed by sleep staging of hdEEG data |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change in sleepiness | Before to after approximately 8 hours of sleep with and without acoustic stimulation | assessed by Karolinska Sleepiness Scale or Stanford Sleepiness Scale |
| Body composition | 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 |
| Hip-to-waist ratio | 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 |
| Body mass index | 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 |
| Chronotype | During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit) | Assessment of circadian type |
| Incidence of Intervention-related Adverse Events (Safety and Tolerability) | Through study completion approximately one month | Any adverse or serious adverse event during the study period will be assessed |
| Daytime sleepiness | During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit) | assessed by Epworth sleepiness scale |
| Subjective sleep quality | During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit) | assessed by Pittsburgh Sleep quality index |
Countries
Switzerland
Outcome results
None listed