Skip to content

Effects of Bio-Sonification Intervention on Sleep Onset and Maintenance

Clinical Trial for Validating Sleep Efficiency of the BELL-001

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0010216
Enrollment
10
Registered
2025-02-21
Start date
2023-10-07
Completion date
Unknown
Last updated
2025-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Others(Mobile Application) : Group 1 receives no treatment during the first visit and undergoes biofeedback-based music therapy during the second visit. Group 2 receives biofeedback-based music therap

Sponsors

Korea Research Institute of Standards and Science
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants will be men and women aged 20 to 40 who experience persistent difficulty initiating sleep. Reference to DSM-5 Insomnia Criteria Insomnia is diagnosed when an individual consistently experiences any of the following conditions: 1) Difficulty initiating sleep, 2) Frequent awakenings during sleep, 3) Early morning awakenings with difficulty falling back asleep, 4) Feeling unrefreshed despite sleep For this study, only individuals who subjectively experience difficulty falling asleep (Condition 1) will be recruited.

Exclusion criteria

Exclusion criteria: - Individuals with physical conditions such as spinal or neck disorders - Individuals with cognitive impairments - Individuals outside the 20–40 age range

Design outcomes

Primary

MeasureTime frame
Change in Sleep Onset Latency (SOL) in the Intervention Condition Compared to the Control Condition

Secondary

MeasureTime frame
Change in Sleep Efficiency (SE) in the Intervention Condition Compared to the Control Condition;Change in Wake After Sleep Onset (WASO) in the Intervention Condition Compared to the Control Condition;Change in Total Sleep Time (TST) in the Intervention Condition Compared to the Control Condition;Change in the Proportion of Each Sleep Stage in the Intervention Condition Compared to the Control Condition;Change in the Mean Score of the Five Subcategories of K-RCSQ (Korean Version of the Richards-Campbell Sleep Questionnaire) in the Intervention Condition Compared to the Control Condition;Change in Sleep Depth Score (K-RCSQ) in the Intervention Condition Compared to the Control Condition ;Change in Falling Asleep Score (K-RCSQ) in the Intervention Condition Compared to the Control Condition;Change in Awakening Score (K-RCSQ) in the Intervention Condition Compared to the Control Condition;Change in Returning to Sleep Score (K-RCSQ) in the Intervention Condition Compared to the Control Condition;Change in Overall Sleep Quality Score (K-RCSQ) in the Intervention Condition Compared to the Control Condition

Countries

Korea, Republic of

Contacts

Public ContactDa-Mee Kim

Korea Research Institute of Standards and Science

dameeing@kriss.re.kr+82-42-868-5860

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026