Clinical trial NCT06322524: Study on Gamma Sensory Flicker for Insomnia
Official title: Shanxi Key Laboratory of Artificial Intelligence Assisted Diagnosis and Treatment for Mental Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Quality
Sleep Duration
Sleep Onset Latency
Keywords: gamma sensory flicke
insomnia
sleep quality
adherence
adverse effect
Lead sponsor: The First Affiliated Hospital of Shanxi Medical University
Sponsor class: OTHER
Collaborators: name: Shanxi Medical University
First posted: 2024-03-21
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants aged 18 to 70, of any gender, must have completed at least primary school education with a minimum of 5 years of schooling, possess the ability to comprehend instructional language, willingly provide informed consent, and demonstrate adherence to the research protocol.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment adherence rate
timeFrame: 8 weeks （56 days）
measure: Patient treatment adherence rate
timeFrame: 8 weeks （56 days）
measure: Incidence rate of adverse reaction
timeFrame: 8 weeks
measure: Differences in sleep duration between the first and eighth weeks
timeFrame: 8 weeks
measure: Differences in sleep onset latencies between the first and eighth weeks
timeFrame: 8 weeks
measure: Differences in awakening times between the first and eighth weeks
timeFrame: 8 weeks
Secondary outcomes:
measure: pre-sleep efficiency.
timeFrame: pre-intervention
measure: post-sleep efficiency.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Yong Xu
state: Shanxi
Study officials:
References:
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