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Completed

NCT Number: NCT06322524

Study on Gamma Sensory Flicker for Insomnia

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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Key information

Conditions

Sleep Quality Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Duration Sleep Initiation and Maintenance Disorders Sleep Onset Latency Sleep Wake Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yong Xu

Taiyuan, Shanxi, 030000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gamma sensory flicker

Device

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

Primary outcomes

  1. Treatment adherence rate

    Time frame: 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%

  2. Patient treatment adherence rate

    Time frame: 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%

  3. Incidence rate of adverse reaction

    Time frame: 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%

  4. Differences in sleep duration between the first and eighth weeks

    Time frame: 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.

  5. Differences in sleep onset latencies between the first and eighth weeks

    Time frame: 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.

  6. Differences in awakening times between the first and eighth weeks

    Time frame: 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.

Secondary outcomes

  1. pre-sleep efficiency.

    Time frame: pre-intervention

    Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography.

  2. post-sleep efficiency.

    Time frame: 8 weeks

    Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Shanxi Medical University

Other

Collaborators

  • Shanxi Medical University

Registry information

Official study title

Shanxi Key Laboratory of Artificial Intelligence Assisted Diagnosis and Treatment for Mental Disorder

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 21, 2024
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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