HealthySleep-ISO IIINCT03681327
Sleep Infra-slow Oscillations III
A study testing Sensory stimulation during sleep in people with Healthy, run by Neurocenter of Southern Switzerland at 1 site in Switzerland.
Trial summary
In young healthy subjects, we will apply sensory stimuli at specific times during sleep to evaluate the probability that the stimulus evokes an arousal. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sensory stimulation during sleep
- How many people
- 17 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2018to 1 Jul 2023
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willingness to participate and written informed consent
- Aged 20 to 40 years at the time of screening
- Body mass index (BMI) ≤ 30
Who cannot join
- Pregnancy or breast feeding at the time of screening
- Sleep related breathing disorders
- Any other sleep related breathing disorder according to AASM criteria
- Current history of psychiatric disorders according to DSM-V
- Current chronic treatment that may affect sleep
- Any significant neurological disorder or other medical disease that may affect sleep
- Any unstable medical condition
- Any clinically significant sleep disorder
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Neurocenter of Southern Switzerland
Lugano, Canton Ticino, 6903
About this study
Official title: Sleep Infra-slow Oscillations III: an Observational Study in Healthy Subjects and Patients With Sleep Disorders With and Without Closed-loop Stimulation During Sleep
In young healthy subjects, we will apply sensory stimuli at specific times during sleep to evaluate the probability that the stimulus evokes an arousal.
- Conditions
- Healthy
- Being tested
- Sensory stimulation during sleep
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensory stimulation during sleepOther
Sensory stimulation during sleep
What is being measured
The primary outcome is the main question the study is designed to answer.
Arousal probability
Number stimuli that are followed by an EEG arousal divided by the total number of stimuli
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Oct 2018
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neurocenter of Southern Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephany Fulda, Neurocenter of Southern Switzerland
- Investigators
- Stephany Fulda, PhD, Principal investigator, Neurocenter of Southern Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03681327
- Sponsor's protocol ID
- EOC.NSI.LS.18.1
- Acronym
- Sleep-ISO III
- Status last verified
- Nov 2023
- First submitted
- 20 Sep 2018
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data and metadata generating in this project will be deposited onto existing public repositories.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Infra-slow Oscillations III: an Observational Study in Healthy Subjects and Patients With Sleep Disorders With and Without Closed-loop Stimulation During Sleep
- ClinicalTrials.gov ID
- NCT03681327
- Acronym / sponsor ID
- Sleep-ISO III / EOC.NSI.LS.18.1
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Neurocenter of Southern SwitzerlandUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 24 Sep 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.
In young healthy subjects, we will apply sensory stimuli at specific times during sleep to evaluate the probability that the stimulus evokes an arousal.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willingness to participate and written informed consent
- Aged 20 to 40 years at the time of screening
- Body mass index (BMI) ≤ 30
Key exclusion criteria (8 listed)
- Pregnancy or breast feeding at the time of screening
- Sleep related breathing disorders
- Any other sleep related breathing disorder according to AASM criteria
- Current history of psychiatric disorders according to DSM-V
- Current chronic treatment that may affect sleep
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 |
|---|---|---|
| Sensory stimulation during sleepSensory stimulation during sleep | Other | – |
Primary outcome
Arousal probability
Time frame: 8 hours
Number stimuli that are followed by an EEG arousal divided by the total number of stimuli
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 8 Nov 2023.
- Individual participant dataSharing planned: Yes. The data and metadata generating in this project will be deposited onto existing public repositories.
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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.
Stephany Fulda, PhD principal investigator
Neurocenter of Southern Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensory stimulation during sleep in people with Healthy, run by Neurocenter of Southern Switzerland 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 3 inclusion and 8 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 8 Nov 2023. 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. 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?
Arousal probability (time frame: 8 hours). 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 8 Nov 2023.