Study on Gamma Sensory Flicker for Insomnia

Completed

• Conditions: Sleep Quality; Sleep Duration; Sleep Onset Latency
• Interventions: Device: Gamma sensory flicker

• Registration Number: NCT06322524
• Lead Sponsor: The First Affiliated Hospital of Shanxi Medical University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-05-01
• Primary Completion: 2022-03-30
• Study Completion: 2022-12-30
• Status Verified: 2024-03
• Study First Submitted: 2024-03-05
• Study First Submitted QC: 2024-03-20
• Last Update Submitted: 2024-03-20
• Study First Posted: 2024-03-21
• Last Update Posted: 2024-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 37

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
insomnia group	Gamma sensory flicker	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.

Primary Outcome Measures

Name	Time	Method
Differences in sleep duration between the first and eighth weeks	8 weeks	Keep sleep diaries for the first and eighth weeks of treatment.; A comparison of average sleep duration （hour） between the first and eighth weeks of treatment.
Treatment adherence rate	8 weeks （56 days）	Participants adhered well to flicker therapy over eight weeks, as measured by the percentage of days they used the device out of the total days they were assigned to use it.; Treatment adherence rate = days the patient completed treatment on time/56 days×100%
Differences in sleep onset latencies between the first and eighth weeks	8 weeks	Keep sleep diaries for the first and eighth weeks of treatment.; A comparison of average sleep onset latencies （min）between the first and eighth weeks of treatment.
Differences in awakening times between the first and eighth weeks	8 weeks	Keep sleep diaries for the first and eighth weeks of treatment.; A comparison of average waking times （times） between the first and eighth weeks of treatment.
Incidence rate of adverse reaction	8 weeks	Describe the specific situation of adverse reactions, including types, frequency, severity, and whether they have been relieved.; Incidence rate of adverse reactions = number of people experiencing adverse reactions/total number of people participating in treatment x 100%
Patient treatment adherence rate	8 weeks （56 days）	Participants adhered well to flicker therapy over eight weeks, as measured by the percentage of days they used the device out of the total days they were assigned to use it.; Patient treatment adherence rate = sum of all treatment adherence rates / number of patients participating in treatment×100%

Secondary Outcome Measures

Name	Time	Method
pre-sleep efficiency.	pre-intervention	Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography.
post-sleep efficiency.	8 weeks	Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography.

Trial Locations

Locations (1)

Yong Xu; 🇨🇳 Taiyuan, Shanxi, China