Clinical trial NCT04166916: Role of Sleep in Cardiovascular Functions
Official title: Modulation of Sleep Slow Wave Activity Through Acoustic Stimulation and Its Consequences on Cardiovascular Functions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 71
Sex: MALE
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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).
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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),

Primary outcomes:
measure: Cardiac autonomic regulation
timeFrame: continuously across approximately 8 hours of sleep with and without acoustic stimulation
measure: Change in cardiac autonomic regulation
timeFrame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
measure: Heart rate
timeFrame: continuously across approximately 8 hours of sleep with and without acoustic stimulation
measure: Change in heart rate
timeFrame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
measure: Marker for sleep depth
timeFrame: continuously across approximately 8 hours of sleep with and without acoustic stimulation
Secondary outcomes:
measure: Change in vascular functioning
timeFrame: Before and/or after approximately 8 hours of sleep with and without acoustic stimulation
measure: Arterial pressure waveform
timeFrame: continuously across approximately 8 hours of sleep with and without acoustic stimulation
measure: Change in arterial pressure waveform
timeFrame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
measure: Oxyen saturation
timeFrame: continuously across approximately 8 hours of sleep with and without acoustic stimulation
measure: Overnight memory consolidation
timeFrame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
measure: Changes in vigilance
timeFrame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
measure: Changes in muscular fatigue
timeFrame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
measure: Changes in bandwidth of of 0.5-30 Hz of high-density electroencephalography (hdEEG)
timeFrame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
measure: Hypnogram
timeFrame: Over approximately 8 hours of sleep with and without acoustic stimulation
Other outcomes:
measure: Incidence of Intervention-related Adverse Events (Safety and Tolerability)
timeFrame: Through study completion approximately one month
measure: Chronotype
timeFrame: During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit)
measure: Body mass index
timeFrame: During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit)
measure: Hip-to-waist ratio
timeFrame: During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit)
measure: Subjective sleep quality
timeFrame: During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit)
measure: Daytime sleepiness
timeFrame: During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit)
measure: Change in sleepiness
timeFrame: Before to after approximately 8 hours of sleep with and without acoustic stimulation
measure: Body composition
timeFrame: During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit)
Locations:
city: Zurich
country: Switzerland
facility: ETH Zurich
state: Schweiz
Study officials:
affiliation: ETH Zurich
name: Caroline Lustenberger, PhD
role: PRINCIPAL_INVESTIGATOR
References: