Autonomous Sensory Meridian ResponseNCT05266508
Effects of ASMR on the Default Mode Network
An observational study of Autonomous Sensory Meridian Response and Audiobook, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
Trial summary
This study investigates the effects of Autonomous Sensory Meridian Response (ASMR) stimulation on resting-state brain networks. Therefore, two resting-state fMRI scans are measured in healthy adults. Before each fMRI scan, subjects listen either to ASMR typical sounds or an audio-book (randomized cross-over-design). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Autonomous Sensory Meridian Response, Audiobook
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 15 Feb 2022to 15 Aug 2023
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy subjects aged 18 to 99
Who may be able to join
- adults aged 18 to 99
Who cannot join
- mental disorders (dementia, depression)
- MRI contraindications
- claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Effects of Autonomous Sensory Meridian Response (ASMR) Stimulation on the Functional Connectivity of the Default Mode Network
This study investigates the effects of Autonomous Sensory Meridian Response (ASMR) stimulation on resting-state brain networks. Therefore, two resting-state fMRI scans are measured in healthy adults. Before each fMRI scan, subjects listen either to ASMR typical sounds or an audio-book (randomized cross-over-design). It is expected to find changes in the functional connectivity of the Default Mode Network caused by passive listening to ASMR.
Read the detailed description
ASMR describes a phenomenon of a perceived tingling caused by visual or auditory stimulation. This sensation can spread from the neck to the scalp and further to the back and the extremities. The triggering sound often consists of acoustic sounds (crackle, whisper, light nail-tapping) or visual images (e.g., someone is combing their hair), leading to a calm and relaxing feeling. Although ASMR is ubiquitous in platforms like "YouTube", there are just a few studies investigating the effects of ASMR. In one of those studies, Smith and colleagues examined the Default Mode Network of 11 subjects with ASMR stimulation and compared the outcome with a control group consisting of 11 subjects. They found reduced functional connectivity in the ASMR group compared to the control group. Furthermore, the connectivity between the occipital, frontal and temporal cortex was increased.
In the present study, fMRI is used to examine the effects of ASMR stimulation in a randomized cross-over design. Half of the subjects (n=14) receive the ASMR stimulation first, and then the control stimulation (audiobook). The other half of the subjects (n=14) listens to the control stimulation (audiobook) first and afterward to the ASMR stimulation. Typical "tingling" triggering sounds are presented via MRI-compatible headphones. Those sounds can consist of different noises (e.g., whisper, scratching, and knocking).
The primary outcome measure is a change in the functional connectivity of the Default Mode Network as a response to the ASMR stimulation.
- Conditions
- Autonomous Sensory Meridian Response, Audiobook
- Keywords
- Autonomous Sensory Meridian Response, Resting-state fMRI, Default Mode Network
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed functional connectivity
Functional connectivity is measured using resting-state fMRI
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start15 Feb 2022
- Primary completion2 May 2022
- Study completion15 Aug 2023
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 Autonomous Sensory Meridian ResponseStudies 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- BDH-Klinik Hessisch Oldendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jens D. Rollnik, MD, Study director, BDH-Clinik Hessisch Oldendorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266508
- Sponsor's protocol ID
- ASMR-EFF
- Status last verified
- Aug 2024
- First submitted
- 23 Feb 2022
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smith SD, Fredborg BK, Kornelsen J. Atypical Functional Connectivity Associated with Autonomous Sensory Meridian Response: An Examination of Five Resting-State Networks. Brain Connect. 2019 Jul;9(6):508-518. doi: 10.1089/brain.2018.0618. Epub 2019 May 7.
PubMed 30931592
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Autonomous Sensory Meridian Response (ASMR) Stimulation on the Functional Connectivity of the Default Mode Network
- ClinicalTrials.gov ID
- NCT05266508
- Acronym / sponsor ID
- ASMR-EFF
- Conditions
- Autonomous Sensory Meridian Response, Audiobook
- Keywords
- Autonomous Sensory Meridian Response, Resting-state fMRI, Default Mode Network
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- BDH-Klinik Hessisch OldendorfUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 4 Mar 2022 (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 study investigates the effects of Autonomous Sensory Meridian Response (ASMR) stimulation on resting-state brain networks. Therefore, two resting-state fMRI scans are measured in healthy adults. Before each fMRI scan, subjects listen either to ASMR typical sounds or an audio-book (randomized cross-over-design). It is expected to find changes in the functional connectivity of the Default Mode Network caused by passive listening to ASMR.
Detailed description
ASMR describes a phenomenon of a perceived tingling caused by visual or auditory stimulation. This sensation can spread from the neck to the scalp and further to the back and the extremities. The triggering sound often consists of acoustic sounds (crackle, whisper, light nail-tapping) or visual images (e.g., someone is combing their hair), leading to a calm and relaxing feeling. Although ASMR is ubiquitous in platforms like "YouTube", there are just a few studies investigating the effects of ASMR. In one of those studies, Smith and colleagues examined the Default Mode Network of 11 subjects with ASMR stimulation and compared the outcome with a control group consisting of 11 subjects. They found reduced functional connectivity in the ASMR group compared to the control group. Furthermore, the connectivity between the occipital, frontal and temporal cortex was increased.
In the present study, fMRI is used to examine the effects of ASMR stimulation in a randomized cross-over design. Half of the subjects (n=14) receive the ASMR stimulation first, and then the control stimulation (audiobook). The other half of the subjects (n=14) listens to the control stimulation (audiobook) first and afterward to the ASMR stimulation. Typical "tingling" triggering sounds are presented via MRI-compatible headphones. Those sounds can consist of different noises (e.g., whisper, scratching, and knocking).
The primary outcome measure is a change in the functional connectivity of the Default Mode Network as a response to the ASMR stimulation.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy subjects aged 18 to 99
Key inclusion criteria (1 listed)
- adults aged 18 to 99
Key exclusion criteria (3 listed)
- mental disorders (dementia, depression)
- MRI contraindications
- claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Changed functional connectivity
Time frame: 45 minutes
Functional connectivity is measured using resting-state fMRI
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 7 Aug 2024.
- Background: PubMed 30931592Smith SD, Fredborg BK, Kornelsen J. Atypical Functional Connectivity Associated with Autonomous Sensory Meridian Response: An Examination of Five Resting-State Networks. Brain Connect. 2019 Jul;9(6):508-518. doi: 10.1089/brain.2018.0618. Epub 2019 May 7.
- Individual participant dataSharing planned: No
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.
Jens D. Rollnik, MD study director
BDH-Clinik Hessisch Oldendorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autonomous Sensory Meridian Response and Audiobook, run by BDH-Klinik Hessisch Oldendorf at 1 site in Germany.
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 1 inclusion and 3 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 7 Aug 2024. 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 Germany. 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?
Changed functional connectivity (time frame: 45 minutes). 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 NCT05266508, 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 7 Aug 2024.