NCT06597110

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 5, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 6, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 4, 2024

Completed
15 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

3 months

First QC Date

September 4, 2024

Last Update Submit

September 12, 2024

Conditions

Keywords

adolescent sleepASMRsleep interventionsleep quality scale

Outcome Measures

Primary Outcomes (1)

  • 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.

    0ne month

Secondary Outcomes (1)

  • effective sleep time

    0ne month

Study Arms (4)

control group

NO INTERVENTION

participants with no ASMR intervention

intervention group A

EXPERIMENTAL

participants engaged in pre-sleep ASMR listening sessions lasting 10 mins

Behavioral: listened to ASMR

intervention group B

EXPERIMENTAL

participants engaged in pre-sleep ASMR listening sessions lasting 20 mins

Behavioral: listened to ASMR

intervention group C

EXPERIMENTAL

participants engaged in pre-sleep ASMR listening sessions lasting 30 mins

Behavioral: listened to ASMR

Interventions

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.

Also known as: listern, ASMR
intervention group Aintervention group Bintervention group C

Eligibility Criteria

Age15 Years - 19 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Haven\'t heard an ASMR trigger tone before.

You may not qualify if:

  • heard an ASMR trigger tone before.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Huiping Zhang, doctor

    Huazhong University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate pfofessor

Study Record Dates

First Submitted

September 4, 2024

First Posted

September 19, 2024

Study Start

May 5, 2023

Primary Completion

August 6, 2023

Study Completion

September 15, 2023

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, ICF, CSR

Locations