Clinical trial NCT03420677: Enhancement of Sleep With Wearables
Official title: Enhancement of Sleep Slow Wave Activity Using Wearable Auditory Stimulation Devices and Its Consequences on Daytime Functioning: a Randomized, Counter-balanced Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
First posted: 2018-02-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 84
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Sleep quality
timeFrame: From baseline period to study completion, assessed up to 2 months
Secondary outcomes:
measure: Daily functioning - Mood
timeFrame: 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
measure: Daily functioning - Quality of life
timeFrame: 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
measure: Daily functioning - Vigilance
timeFrame: 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
measure: Daily functioning - Cognition
timeFrame: 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
measure: Physiological parameters - Cardiovascular
timeFrame: From baseline period to study completion, assessed up to 2 months
measure: Physiological parameters - Physical activity
timeFrame: Through study completion, approximately 2 months
Other outcomes:
measure: Device usability
timeFrame: From the first home visit until the end of the second intervention period, assessed within a time period up to 2 months
measure: Diary
timeFrame: Through study completion, approximately 2 months
measure: Incidence of Intervention-related Adverse Events [Safety and Tolerability]
timeFrame: Through study completion, approximately 2 months
measure: Chronotype
timeFrame: Before start of intervention period (single-time assessment during one initial 1-day visit)
measure: Handedness
timeFrame: Before start of intervention period (single-time assessment during one initial 1-day visit)
measure: Menstrual cycle
timeFrame: Before start of intervention period (single-time assessment during one initial 1-day visit)
measure: Height
timeFrame: Before start of intervention period (single-time assessment during one initial 1-day visit)
measure: Hip-to-waist ratio
timeFrame: Before start of intervention period (single-time assessment during one initial 1-day visit)
measure: Blood pressure
timeFrame: Through study completion, approximately 2 months
measure: Weight
timeFrame: Before start of intervention period (single-time assessment during one initial 1-day visit)
Locations:
city: Zürich
country: Switzerland
facility: Swiss Federal Institute of Technology
state: Zurich
Study officials:
References:
citation: Lustenberger C, Ferster ML, Huwiler S, Brogli L, Werth E, Huber R, Karlen W. Auditory deep sleep stimulation in older adults at home: a randomized crossover trial. Commun Med (Lond). 2022 Apr 4;2:30. doi: 10.1038/s43856-022-00096-6. eCollection 2022.