InsomniaASMR on sleepNCT06597110
The Effects of Autonomous Sensory Meridian Response (ASMR) on Sleep Quality Improvement in Adolescents
A study testing listened to ASMR in people with Insomnia and Sleep Quality, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
Background: This study explored the therapeutic impact of ASMR on sleep problems in high school students. Methods: The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. Read more about this study
- Who is it for?
- Ages 15 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Insomnia, Sleep Quality
- What is being tested?
- listened to ASMR
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2023to 15 Sep 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 15 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Haven\'t heard an ASMR trigger tone before.
Who cannot join
- heard an ASMR trigger tone before.
Trial locations and contacts
1 site in 1 country.
About this study
Background: This study explored the therapeutic impact of ASMR on sleep problems in high school students.
Methods: The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.
Read the detailed description
Background: In recent years, there has been a notable surge in sleep-related challenges among adolescents. The emergence of Autonomous Sensory Meridian Response (ASMR) content across various social media platforms has sparked interest in its potential to address these issues. This study explored the therapeutic impact of ASMR on sleep problems in high school students.
Methods: The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.
- Conditions
- Insomnia, Sleep Quality
- Being tested
- listened to ASMR
- Keywords
- adolescent sleep, ASMR, sleep intervention, sleep quality scale
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
listened to ASMRBehavioural
Also called listern, ASMR
ASMR refers to a physiological sensation triggered by specific auditory stimuli.ASMR, characterized by low-frequency human voice and ambient sounds, has garnered significant attention across social media platforms, short and long-form video platforms, and podcasts, owing to its unique pleasurable and stimulating effects. listen to ASMR for 10mins.
| Study group | Role | What they receive |
|---|---|---|
| control group | No intervention | participants with no ASMR intervention |
| intervention group A | Experimental | participants engaged in pre-sleep ASMR listening sessions lasting 10 mins Receives: Behavioral: listened to ASMR |
| intervention group B | Experimental | participants engaged in pre-sleep ASMR listening sessions lasting 20 mins Receives: Behavioral: listened to ASMR |
| intervention group C | Experimental | participants engaged in pre-sleep ASMR listening sessions lasting 30 mins Receives: Behavioral: listened to ASMR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pittsburgh Sleep Quality Index
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire designed to assess sleep quality and disturbances over a one-month period. It consists of 19 questions covering various aspects of sleep, such as sleep duration, latency, efficiency, and disturbances. The responses are used to calculate a global score, with higher scores indicating poorer sleep quality. It\'s commonly used in clinical and research settings to evaluate sleep-related issues and their impact on overall health.
Measured: 0ne month
Secondary outcomes (1)
effective sleep time
effective sleep time
Measured: 0ne month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start5 May 2023
- Primary completion6 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kai Zhao, Huazhong University of Science and Technology
- Investigators
- Huiping Zhang, doctor, Principal investigator, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597110
- Sponsor's protocol ID
- HUST-2023-108
- Other IDs
- KF202202
- Acronym
- ASMR on sleep
- Status last verified
- Sep 2024
- First submitted
- 4 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Autonomous Sensory Meridian Response (ASMR) on Sleep Quality Improvement in Adolescents
- ClinicalTrials.gov ID
- NCT06597110
- Acronym / sponsor ID
- ASMR on sleep / HUST-2023-108
- Conditions
- Insomnia, Sleep Quality
- Keywords
- adolescent sleep, ASMR, sleep intervention, sleep quality scale
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 5 May 2023 (actual)
- Primary completion
- 6 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 19 Sep 2024 (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.
Background: This study explored the therapeutic impact of ASMR on sleep problems in high school students.
Methods: The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.
Detailed description
Background: In recent years, there has been a notable surge in sleep-related challenges among adolescents. The emergence of Autonomous Sensory Meridian Response (ASMR) content across various social media platforms has sparked interest in its potential to address these issues. This study explored the therapeutic impact of ASMR on sleep problems in high school students.
Methods: The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study involved sixty participants, divided evenly into four groups: three intervention groups (A, B, C) and one control group. For five consecutive days, the intervention groups engaged in pre-sleep ASMR listening sessions lasting 10, 20, and 30 minutes, respectively. Sleep quality was evaluated using mobile application tools and the subjective Sleep Quality Scale.
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –participants with no ASMR intervention |
| intervention group A | Experimental | Behavioral: listened to ASMRparticipants engaged in pre-sleep ASMR listening sessions lasting 10 mins |
| intervention group B | Experimental | Behavioral: listened to ASMRparticipants engaged in pre-sleep ASMR listening sessions lasting 20 mins |
| intervention group C | Experimental | Behavioral: listened to ASMRparticipants engaged in pre-sleep ASMR listening sessions lasting 30 mins |
Who may qualify
- Ages
- 15 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Haven\'t heard an ASMR trigger tone before.
Key exclusion criteria (1 listed)
- heard an ASMR trigger tone before.
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 |
|---|---|---|
| listened to ASMRAlso: listern, ASMRASMR refers to a physiological sensation triggered by specific auditory stimuli.ASMR, characterized by low-frequency human voice and ambient sounds, has garnered significant attention across social media platforms, short and long-form video platforms, and podcasts, owing to its unique pleasurable and stimulating effects. listen to ASMR for 10mins. | Behavioural | intervention group A, intervention group B, intervention group C |
Primary outcome
Pittsburgh Sleep Quality Index
Time frame: 0ne month
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire designed to assess sleep quality and disturbances over a one-month period. It consists of 19 questions covering various aspects of sleep, such as sleep duration, latency, efficiency, and disturbances. The responses are used to calculate a global score, with higher scores indicating poorer sleep quality. It\'s commonly used in clinical and research settings to evaluate sleep-related issues and their impact on overall health.
1 secondary outcome
effective sleep time
Time frame: 0ne month
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 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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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.
Huiping Zhang, doctor principal investigator
Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing listened to ASMR in people with Insomnia and Sleep Quality, run by Huazhong University of Science and Technology at 1 site in China.
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 1 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 19 Sep 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 China. 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?
Pittsburgh Sleep Quality Index (time frame: 0ne month). 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 19 Sep 2024.