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The mechanism study of dynamic soundscape therapy for insomnia based on sleep structure

The mechanism study of dynamic soundscape therapy for insomnia based on sleep structure

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300079293
Enrollment
Unknown
Registered
2023-12-29
Start date
2023-12-30
Completion date
Unknown
Last updated
2024-01-08

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

Conditions

chronic insomnia

Interventions

Online soundscape intervention group:Soundscape intervention. Every participants undergo continuous 13 nights online sleep monitoring, with 12 nights soundscape listening and 1 night control. The cont
Sleep-aiding soundscape intervention polysomnography monitoring experiment:Soundscape intervention. Every participants undergo continuous 7 nights of PSG sleep monitoring. The first day is the adaptat
Long-term soundscape intervention experiment - control group:Control group. Participants sleep normally for 2 weeks, during which no sleep assistance measures will be taken. Psychological questionnair
Long-term soundscape intervention experiment - dynamic soundscape treatment group:Long-term whole-process dynamic soundscape intervention. Participants listen to soundscape continuously for 2 weeks du
Long-term soundscape intervention experiment - dynamic soundscape treatment group after falling asleep:Long-term dynamic soundscape intervention after falling asleep. Participants select from 10 repre

Sponsors

Chongqing University Three Gorges Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Mainly manifested by difficulty falling asleep (SOL>30min), sleep maintenance disorder (number of awakenings = 2 times throughout the night), early awakening, resulting in decreased sleep quality and/or reduced total sleep time (usually less than 6.5h). Also accompanied by daytime dysfunction (including fatigue/physical discomfort, depression/agitation/cognitive impairment, etc.); (2) Use the internationally accepted Pittsburgh Sleep Quality Index questionnaire to conduct a preliminary assessment of the recruited samples, and select the Pittsburgh Sleep Quality Index Insomnia patients whose (PSQI) is greater than 7; (3) refer to the "Chinese Adult Insomnia Diagnosis and Treatment Guidelines" to select insomnia patients whose insomnia duration exceeds 3 months and/or the frequency of related symptoms reaches at least 3 times a week; (4) ) The dominant hand is the right hand, and the body mass index (BMI) is between 18.5 and 23.9; (5) Able to use a smartphone independently and have the ability to read and fill out questionnaires.

Exclusion criteria

Exclusion criteria: (1) Being pregnant or trying to become pregnant; (2) Restless legs, apnea, drowsiness, abnormal sleep and other sleep disorders (Epworth Sleepiness Scale >11 points); (3) Suffering from hearing impairment; (4) Suffering from Basic diseases (such as hypertension, diabetes, etc.); (5) Suffering from severe depression (PHQ-9 Depression Screening Scale =15 points); (6) Have ever received or are currently receiving cognitive behavioral therapy for insomnia, such as Follow the doctor's advice to perform certain sleep compression, etc.; (7) Have the habit of meditating or relaxing within 30 minutes before going to bed at night; (8) Have a history of drug abuse and alcoholism; (9) Use drugs that affect sleep, such as sleeping pills, sedatives, and antibiotics. Depressants, anticholinergics, antihistamines, sedatives, melatonin, etc.; (10) During the day during the experiment, eat food containing alcohol and caffeine, engage in strenuous physical activities, and during high-intensity work and study (Such as long-distance driving, shift work, preparing for exams, postgraduate entrance exams, etc.); (11) Difficulty falling asleep in an unfamiliar environment, and abnormal sleep schedules.

Design outcomes

Primary

MeasureTime frame
Sleep quality;Sleep diary;Polysomnography Monitoring Report;

Secondary

MeasureTime frame
Soundscape evaluation;Anxiety level;Depression level;Satisfaction;Mood;

Countries

China

Contacts

Public ContactHaishui Duan

Chongqing University Three Gorges Hospital

18496093@qq.com+86 138 9691 8650

Outcome results

None listed

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