CompletedNot Applicable

Study on Gamma Sensory Flicker for Insomnia

China37 participantsStarted 2021-05-01

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Treatment adherence rate

Timeframe: 8 weeks （56 days）

Patient treatment adherence rate

Timeframe: 8 weeks （56 days）

Incidence rate of adverse reaction

Timeframe: 8 weeks

Differences in sleep duration between the first and eighth weeks

Timeframe: 8 weeks

Differences in sleep onset latencies between the first and eighth weeks

Timeframe: 8 weeks

Differences in awakening times between the first and eighth weeks

Timeframe: 8 weeks

Trial details

NCT IDNCT06322524

SponsorThe First Affiliated Hospital of Shanxi Medical University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-03-30

View on ClinicalTrials.gov More Sleep Quality trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Treatment adherence rate

Timeframe: 8 weeks （56 days）

Patient treatment adherence rate

Timeframe: 8 weeks （56 days）

Incidence rate of adverse reaction

Timeframe: 8 weeks

Differences in sleep duration between the first and eighth weeks

Timeframe: 8 weeks

Differences in sleep onset latencies between the first and eighth weeks

Timeframe: 8 weeks

Differences in awakening times between the first and eighth weeks

Timeframe: 8 weeks