Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep OptimizationNCT03323814
Enhancing Sleep Slow Waves Using External Stimuli
An observational study of Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, run by University of Wisconsin, Madison.
Trial summary
This is an observational study to determine if the presentation of sensory stimulation during sleep can increase slow-wave activity during non-rapid eye movement sleep Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization
- What is being tested?
- Slow-wave optimization
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2009to 13 Jun 2019
- Phase
- Observational
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 100 healthy volunteers will participatea)
Who may be able to join
None listed.
Who cannot join
- Subjects taking medications that could affect sleep patterns (based on self-report and review with a study clinician).
- Subjects who have had travel in the last 2 weeks or who intend to travel during the 4 experimental weeks (for at-home subjects) with time zone shifts >1h;
- The investigator anticipates that the subject will be unable to comply with the protocol.
- Individuals who self-report a current severe or chronic medical condition or sleep disorder that may affect sleep patterns (based on self-report and review with a study clinician).
- Individuals who self-report a history of recurrent seizures or epilepsy or family history of hereditary epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion).
- Subjects who do report not being consistent in their daily use of alcohol, caffeine, or nicotine.
About this study
Official title: Optimizing Peripheral Sensory Stimulation to Induce Sleep Slow Waves
This is an observational study to determine if the presentation of sensory stimulation during sleep can increase slow-wave activity during non-rapid eye movement sleep
Read the detailed description
This is a single-site,unblinded study at the University of Wisconsin to determine the effectiveness of various stimulation modalities and parameters to maximize effectiveness for increasing slow waves during both nocturnal sleep and during daytime naps The ongoing study is a necessary exploratory step towards the future development of non-pharmacological means to improve sleep by increasing SWA.
Several different stimulation modalities will be examined including: auditory (soft tones delivered to the subject through earphones); somatosensory (brief and painless electrical pulses delivered to the median nerve through electrodes placed at the wrist); vestibular (brief and painless electrical pulses delivered through electrodes placed near the mastoids); olfactory (light puffs of air, with or without mild odorants, delivered to the nostril(s) and/or mouth; visual (brief light flashes via strobe light). The amplitude (stimulus intensity) and frequency (number of stimuli per unit time) of stimulation presentation will be systematically varied to identify the ideal parameters for slow wave induction during sleep. For each stimulation modality and each subject, we will determine the range of stimulus intensity from the minimum level sufficient for perceptual response (e.g. - the lowest volume setting for an auditory stimulus that the subject can hear) to a stimulus level that the subject deems comfortable to still allow sleep. This is particularly important, as sleep maintenance during these experiments requires stimulus intensity low enough to avoid awakening the subject. Additionally, based on previous results from our laboratory, the effective range of stimulus intensity will vary substantially between subjects - both the identified range during wakefulness, as well as the range that induces slow waves but avoids waking during the sleep recording. Given this response variability, during the sleep recordings stimulus intensity will be adjusted, starting with the range determined in waking, to find the optimal intensity to inducing sleep slow waves (based on EEG response patterns), and avoiding subject awakening.
- Being tested
- Slow-wave optimization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Slow-wave optimizationDevice
Also called enhancing slow waves during non-rapid eye movement sleep
employing sensory stimulation to enhance slow waves
| Study group | Role | What they receive |
|---|---|---|
| short-sleepers | subset of participants will be recruited who report less than typical work/ weekday sleep in order to examine whether enhancing sleep with stimulation will reduce the amount of extra sleep subjects usually get on the weekends. Receives: Device: Slow-wave optimization | |
| shift-workers | An additional subset of participants will be recruited who work evening shifts to see if enhanced sleep can counteract some of the effects of schedule shifting. Receives: Device: Slow-wave optimization | |
| normal-sleepers | The first cohort will be used to optimize the the type and duration of sensory stimuli that will optimally enhance slow-waves. Receives: Device: Slow-wave optimization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enhancing slow-wave sleep
increase slow-wave activity during non-rapid eye movement sleep
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start1 Aug 2009
- Primary completion13 Jun 2019
- Study completion13 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep OptimizationStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor
- Investigators
- Guilio Tononi, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323814
- Sponsor's protocol ID
- 2015-0337 (H-2009-0052)
- Other IDs
- A538900, SMPH\PSYCHIATRY\PSYCHIATRY
- Status last verified
- Oct 2020
- First submitted
- 12 Apr 2016
- Last updated
- 14 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Peripheral Sensory Stimulation to Induce Sleep Slow Waves
- ClinicalTrials.gov ID
- NCT03323814
- Acronym / sponsor ID
- 2015-0337 (H-2009-0052)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 1 Aug 2009 (actual)
- Primary completion
- 13 Jun 2019 (actual)
- Study completion
- 13 Jun 2019 (actual)
- First posted
- 27 Oct 2017 (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.
This is an observational study to determine if the presentation of sensory stimulation during sleep can increase slow-wave activity during non-rapid eye movement sleep
Detailed description
This is a single-site,unblinded study at the University of Wisconsin to determine the effectiveness of various stimulation modalities and parameters to maximize effectiveness for increasing slow waves during both nocturnal sleep and during daytime naps The ongoing study is a necessary exploratory step towards the future development of non-pharmacological means to improve sleep by increasing SWA.
Several different stimulation modalities will be examined including: auditory (soft tones delivered to the subject through earphones); somatosensory (brief and painless electrical pulses delivered to the median nerve through electrodes placed at the wrist); vestibular (brief and painless electrical pulses delivered through electrodes placed near the mastoids); olfactory (light puffs of air, with or without mild odorants, delivered to the nostril(s) and/or mouth; visual (brief light flashes via strobe light). The amplitude (stimulus intensity) and frequency (number of stimuli per unit time) of stimulation presentation will be systematically varied to identify the ideal parameters for slow wave induction during sleep. For each stimulation modality and each subject, we will determine the range of stimulus intensity from the minimum level sufficient for perceptual response (e.g. - the lowest volume setting for an auditory stimulus that the subject can hear) to a stimulus level that the subject deems comfortable to still allow sleep. This is particularly important, as sleep maintenance during these experiments requires stimulus intensity low enough to avoid awakening the subject. Additionally, based on previous results from our laboratory, the effective range of stimulus intensity will vary substantially between subjects - both the identified range during wakefulness, as well as the range that induces slow waves but avoids waking during the sleep recording. Given this response variability, during the sleep recordings stimulus intensity will be adjusted, starting with the range determined in waking, to find the optimal intensity to inducing sleep slow waves (based on EEG response patterns), and avoiding subject awakening.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| short-sleepers | – | Device: Slow-wave optimizationsubset of participants will be recruited who report less than typical work/ weekday sleep in order to examine whether enhancing sleep with stimulation will reduce the amount of extra sleep subjects usually get on the weekends. |
| shift-workers | – | Device: Slow-wave optimizationAn additional subset of participants will be recruited who work evening shifts to see if enhanced sleep can counteract some of the effects of schedule shifting. |
| normal-sleepers | – | Device: Slow-wave optimizationThe first cohort will be used to optimize the the type and duration of sensory stimuli that will optimally enhance slow-waves. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 100 healthy volunteers will participatea)
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Subjects taking medications that could affect sleep patterns (based on self-report and review with a study clinician).
- Subjects who have had travel in the last 2 weeks or who intend to travel during the 4 experimental weeks (for at-home subjects) with time zone shifts >1h;
- The investigator anticipates that the subject will be unable to comply with the protocol.
- Individuals who self-report a current severe or chronic medical condition or sleep disorder that may affect sleep patterns (based on self-report and review with a study clinician).
- Individuals who self-report a history of recurrent seizures or epilepsy or family history of hereditary epilepsy or have a history of medical conditions that could increase the chance of seizures (e.g. stroke, aneurysm, brain surgery, structural brain lesion).
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 |
|---|---|---|
| Slow-wave optimizationAlso: enhancing slow waves during non-rapid eye movement sleepemploying sensory stimulation to enhance slow waves | Device | normal-sleepers, shift-workers, short-sleepers |
Primary outcome
Enhancing slow-wave sleep
Time frame: 10 years
increase slow-wave activity during non-rapid eye movement sleep
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 14 Oct 2020.
- Individual participant dataSharing planned: No
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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.
Guilio Tononi, MD, PhD principal investigator
University of Wisconsin, Madison
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep, Slow-wave Sleep, Sleep Enhancement, Sleep Optimization, run by University of Wisconsin, Madison.
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 0 inclusion and 6 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 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Enhancing slow-wave sleep (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2020.