SleepWESANCT03420677
Enhancement of Sleep With Wearables
A study testing Application of tones and No application of tones in people with Sleep, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 84 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Application of tones and No application of tones
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- 7 May 2018to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 84 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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),
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Swiss Federal Institute of Technology
Zurich, Canton of Zurich, 8092
About this study
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
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.
- Conditions
- Sleep
- Being tested
- Application of tones, No application of tones
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of tonesDevice
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
No application of tonesDevice
This is the sham-control intervention; The device will only record biosignals but will not play tones.
| Study group | Role | What they receive |
|---|---|---|
| Application of tones | Active comparator | During non-rapid eye movement (NREM) sleep short tones will be played Receives: Device: Application of tones |
| No application of tones | Sham comparator | During NREM sleep no short tones will be played Receives: Device: No application of tones |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality
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.
Measured: From baseline period to study completion, assessed up to 2 months
Secondary outcomes (6)
Daily functioning - Mood
Mood will be digitally assessed using a daily mood scale over the intervention period
Measured: 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
Daily functioning - Quality of life
Quality of life will be assessed using a World Health Organization (WHO) quality of life assessment before and after each intervention period
Measured: 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
Daily functioning - Vigilance
Vigilance will be assessed using a digital psychomotor vigilance task, assessed daily over the intervention period
Measured: 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
Daily functioning - Cognition
Cognition will be assessed using a digital test battery before and after each intervention
Measured: 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
Physiological parameters - Cardiovascular
R-R interval based assessments will be obtained using wearable monitors
Measured: From baseline period to study completion, assessed up to 2 months
Physiological parameters - Physical activity
Physical activity levels will be obtained using wearable monitors
Measured: Through study completion, approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start7 May 2018
- Primary completion5 Mar 2019
- Study completion30 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03420677
- Sponsor's protocol ID
- WESA_2017-01436
- Acronym
- WESA
- Status last verified
- Mar 2021
- First submitted
- 4 Dec 2017
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35603302
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03420677
- Acronym / sponsor ID
- WESA / WESA_2017-01436
- Conditions
- Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Study start
- 7 May 2018 (actual)
- Primary completion
- 5 Mar 2019 (actual)
- Study completion
- 30 Oct 2020 (actual)
- First posted
- 5 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Application of tones | Active comparator | Device: Application of tonesDuring non-rapid eye movement (NREM) sleep short tones will be played |
| No application of tones | Sham comparator | Device: No application of tonesDuring NREM sleep no short tones will be played |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Application of tonesDuring 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 | Device | Application of tones |
| No application of tonesThis is the sham-control intervention; The device will only record biosignals but will not play tones. | Device | No application of tones |
Primary outcome
Sleep quality
Time frame: 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.
6 secondary outcomes
Daily functioning - Mood
Time frame: 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
Daily functioning - Quality of life
Time frame: 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
Daily functioning - Vigilance
Time frame: 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
Daily functioning - Cognition
Time frame: 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
Physiological parameters - Cardiovascular
Time frame: From baseline period to study completion, assessed up to 2 months
Physiological parameters - Physical activity
Time frame: Through study completion, approximately 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Derived from this study: PubMed 35603302Lustenberger 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.
Related trials for Sleep
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Recruiting
Investigation of the Effects of Sleep Deprivation on Itch and Pain Sensitivity
Histamine, Cowhage
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of tones and No application of tones in people with Sleep, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality (time frame: From baseline period to study completion, assessed up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03420677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.