Sleep
Conditions
Brief summary
Sleep, specifically deep sleep, plays a central role in healthy brain function, cardio-vascular processes, mood and quality of life. Auditory stimulation during one night of sleep has previously been shown to improve deep sleep and along with memory formation in both young and older adults. Yet, it remains unclear whether long-term auditory stimulation considerably improves sleep quality over longer time periods and how it affects daytime functioning such as cognition, mood, quality of life and peripheral functions (e.g. cardio-vascular). Due to the importance of deep sleep for brain and body and the presence of many conditions that involve reduced deep sleep (e.g. ageing) assessing the beneficial impact of long-term sleep enhancement and its consequences is of central interest.This study will assess the effect of auditory stimulation over two weeks (interleaved with a two weeks washout period) in a cohort of healthy young and older adults using portable recording and stimulation devices.
Interventions
DEVICEApplication of tones
During NREM sleep, tones (max. 60 dB) will be played using a portable, safe, in-home device. This device records biosignals (e.g. brain activity) and precisely times the tones during NREM sleep. It was developed and produced by the ETH Zurich and approved for use in this study by Swissmedic
DEVICENo application of tones
This is the sham-control intervention; The device will only record biosignals but will not play tones.
Sponsors
Swiss Federal Institute of Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
* Informed Consent as documented by signature * For women: Hormonal contraception, if menstrual cycle is still present or has been present less than a year ago * Good general health status * Stable home situation (e.g. long-term place to live) that allows for reliable application of intervention for the duration of the study * Male and Female subjects 18-35 years of age or 60-84 years of age * German speaking
Exclusion criteria
* Women who are pregnant or breast feeding, * Known or suspected non-compliance, drug or alcohol abuse, * Intake of sleep altering medication * Inability to follow the procedures of the study, e.g. due to language problems, cognitive deficits * Participation in another study with investigational drug within the 30 days preceding and during the present study, * Presence or history of diagnosed psychiatric/neurologic disorder/lesion of the central nervous system (CNS), * Diagnosed internal disease, * Presence of sleep disorders, * Shift-work (work during the night) or situations that require several awakenings during the night (e.g. newborn) * Travelling more than 2 time zones in the last month before intervention starts or during intervention (study start will be shifted accordingly) * Hearing disability/ hearing aid * Skin disorders/problems in face region that will worsen with /not allow adhesive electrode application * Nicotine/Cannabis use * High caffeine consumption (\> 5 servings/day; including coffee, energy drink)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sleep quality | From baseline period to study completion, assessed up to 2 months | Objective information about sleep macro- and microstructure will be assessed including measures like sleep architecture, amount of slow wave activity (SWA), amount of spindles, awakenings during sleep, and sleep fragmentation. In addition, subjective sleep quality will be obtained by questionnaires every morning over the intervention period. These measures will show whether auditory stimulation enhanced overall sleep quality compared to sham. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physiological parameters - Physical activity | Through study completion, approximately 2 months | Physical activity levels will be obtained using wearable monitors |
| Physiological parameters - Cardiovascular | From baseline period to study completion, assessed up to 2 months | R-R interval based assessments will be obtained using wearable monitors |
| Daily functioning - Vigilance | From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks | Vigilance will be assessed using a digital psychomotor vigilance task, assessed daily over the intervention period |
| Daily functioning - Cognition | From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks | Cognition will be assessed using a digital test battery before and after each intervention |
| Daily functioning - Mood | From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks | Mood will be digitally assessed using a daily mood scale over the intervention period |
| Daily functioning - Quality of life | From the beginning of the first intervention period until the end of the second intervention period, assessed within a time period up to 6 weeks | Quality of life will be assessed using a World Health Organization (WHO) quality of life assessment before and after each intervention period |
Other
| Measure | Time frame | Description |
|---|---|---|
| Height | Before start of intervention period (single-time assessment during one initial 1-day visit) | Assessment of height |
| Hip-to-waist ratio | Before start of intervention period (single-time assessment during one initial 1-day visit) | Assessment of hip and waist circumference |
| Blood pressure | Through study completion, approximately 2 months | Assessment of blood pressure |
| Weight | Before start of intervention period (single-time assessment during one initial 1-day visit) | Assessment of weight |
| Device usability | From the first home visit until the end of the second intervention period, assessed within a time period up to 2 months | Questionnaires will be used to track specific information about the portable intervention device including information about its usability, discomfort and blinding to the condition |
| Diary | Through study completion, approximately 2 months | Information about daily habits will be digitally assessed |
| Incidence of Intervention-related Adverse Events [Safety and Tolerability] | Through study completion, approximately 2 months | Any adverse or serious adverse events during the study period will be assessed |
| Chronotype | Before start of intervention period (single-time assessment during one initial 1-day visit) | Assessment of circadian type |
| Handedness | Before start of intervention period (single-time assessment during one initial 1-day visit) | Assessment of handedness |
| Menstrual cycle | Before start of intervention period (single-time assessment during one initial 1-day visit) | Assessment of menstrual cycle information in woman |
Countries
Switzerland
Outcome results
None listed