Role of Sleep in Cardiovascular Functions

Sleep Clinical Trial

Official title:

Modulation of Sleep Slow Wave Activity Through Acoustic Stimulation and Its Consequences on Cardiovascular Functions

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04166916
• Other study ID #: 2019-01538
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 13, 2020
• Est. completion date: October 2023

Study information

• Verified date: November 2022
• Source: Swiss Federal Institute of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 84 Years

Eligibility

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),

Related Conditions & MeSH terms

• Sleep

Intervention

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

Locations

Country	Name	City	State
Switzerland	ETH Zurich	Zurich	Schweiz

Sponsors (1)

Lead Sponsor	Collaborator
Caroline Lustenberger

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Chronotype	Assessment of circadian type	During initial screening session before start of experimental period (single-time assessment during one initial 1-day visit)
Other	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)
Other	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)
Other	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)
Other	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)
Other	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
Other	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)
Primary	Cardiac autonomic regulation	assessed by heart rate variability derived from electrocardiography	continuously across approximately 8 hours of sleep with and without acoustic stimulation
Primary	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
Primary	Heart rate	measured with electrocardiography	continuously across approximately 8 hours of sleep with and without acoustic stimulation
Primary	Change in heart rate	measured with electrocardiography	Before to after approximately 8 hours of sleep with and without acoustic stimulation
Primary	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
Secondary	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
Secondary	Arterial pressure waveform	assessed by arterial pressure waveform measures	continuously across approximately 8 hours of sleep with and without acoustic stimulation
Secondary	Change in arterial pressure waveform	assessed by arterial pressure waveform measures	Before to after approximately 8 hours of sleep with and without acoustic stimulation
Secondary	Oxyen saturation	assessed by pulse oximetry	continuously across approximately 8 hours of sleep with and without acoustic stimulation
Secondary	Overnight memory consolidation	Assessed by memory tasks	Before to after approximately 8 hours of sleep with and without acoustic stimulation
Secondary	Changes in vigilance	assessed by simple vigilance task	Before to after approximately 8 hours of sleep with and without acoustic stimulation
Secondary	Changes in muscular fatigue	assessed by simple muscular fatigue task	Before to after approximately 8 hours of sleep with and without acoustic stimulation
Secondary	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
Secondary	Hypnogram	assessed by sleep staging of hdEEG data	Over approximately 8 hours of sleep with and without acoustic stimulation