Study on Gamma Sensory Flicker for Insomnia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

37 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-05-01

Study Completion Date

2022-12-30

Brief Summary

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This prospective observational study enrolled adult volunteers for a sleep quality research study through a questionnaire survey distributed via a WeChat two-dimensional code from May 2021 to April 2022. Participants were exposed to flicker stimulation through a light and sound device for a duration of 8 weeks with daily monitoring.

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Detailed Description

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This prospective observational study enrolled adult volunteers for a sleep quality research study through a questionnaire survey distributed via a WeChat two-dimensional code from May 2021 to April 2022. Participants were exposed to flicker stimulation through a light and sound device for a duration of 8 weeks with daily monitoring.

A total of 37 participants underwent polysomnography (PSG) prior to the commencement of the study.

Conditions

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Sleep Quality Sleep Duration Sleep Onset Latency

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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insomnia group

insomnia participants participants underwent polysomnography (PSG), the Insomnia Severity Index (ISI), the Pittsburgh Sleep Quality Index (PSQI), the Self-Rating Anxiety Scale (SAS), and the Self-Rating Depression Scale (SDS). prior to the commencement of the study.

8 weeks of the intervention of Gamma sensory flicker, 30 min per day. After 8 weeks study, participants underwent polysomnography again. In the first week of study, participants were required to keep a daily sleep diary everyday.

In the eighth week of study ,participants were required to keep a daily sleep diary everyday.

Gamma sensory flicker

Intervention Type DEVICE

participants were exposed to flicker stimulation through a light and sound device, the flicker was 40 Hz.

Interventions

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Gamma sensory flicker

participants were exposed to flicker stimulation through a light and sound device, the flicker was 40 Hz.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Clinical diagnosis of insomnia according to DSM-5 Cumulative score of ≥7 on the seven-factor components of the Pittsburgh Sleep Quality Index. Sleep disturbances manifest at least three times per week.

Exclusion Criteria

Secondary insomnia related to other mental disorders Substance-induced sleep disorders Environmental sleep disorders Sleep apnea syndrome. Stroke patients Insomnia caused by physical diseases, Severe ophthalmic diseases Brain tumors Suspected or confirmed history of alcohol or drug abuse Psychoactive drugs Pregnancy Previous participation in clinical trials within the past three months Epilepsy or family history of epilepsy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No