Study on Gamma Sensory Flicker for Insomnia

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

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.

Study Overview

• Status: Completed
• Conditions: Sleep Quality; Sleep Duration; Sleep Onset Latency
• Intervention / Treatment: Device: Gamma sensory flicker

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 Type: Observational
• Enrollment (Actual): 37

Contacts and Locations

Study Locations

• China
  • Shanxi
    • Taiyuan, Shanxi, China, 030000
      • Yong Xu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Gamma sensory flicker; participants were exposed to flicker stimulation through a light and sound device, the flicker was 40 Hz.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment adherence rate	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%	8 weeks （56 days）
Patient treatment adherence rate	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%	8 weeks （56 days）
Incidence rate of adverse reaction	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%	8 weeks
Differences in sleep duration between the first and eighth 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.	8 weeks
Differences in sleep onset latencies between the first and eighth 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.	8 weeks
Differences in awakening times between the first and eighth 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.	8 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Shanxi Medical University
• Collaborators: Shanxi Medical University

Publications and helpful links

General Publications

• Martorell AJ, Paulson AL, Suk HJ, Abdurrob F, Drummond GT, Guan W, Young JZ, Kim DN, Kritskiy O, Barker SJ, Mangena V, Prince SM, Brown EN, Chung K, Boyden ES, Singer AC, Tsai LH. Multi-sensory Gamma Stimulation Ameliorates Alzheimer's-Associated Pathology and Improves Cognition. Cell. 2019 Apr 4;177(2):256-271.e22. doi: 10.1016/j.cell.2019.02.014. Epub 2019 Mar 14.
• Son G, Neylan TC, Grinberg LT. Neuronal and glial vulnerability of the suprachiasmatic nucleus in tauopathies: evidence from human studies and animal models. Mol Neurodegener. 2024 Jan 10;19(1):4. doi: 10.1186/s13024-023-00695-4.
• Fernandez-Ruiz A, Oliva A, Soula M, Rocha-Almeida F, Nagy GA, Martin-Vazquez G, Buzsaki G. Gamma rhythm communication between entorhinal cortex and dentate gyrus neuronal assemblies. Science. 2021 Apr 2;372(6537):eabf3119. doi: 10.1126/science.abf3119.
• Manippa V, Palmisano A, Filardi M, Vilella D, Nitsche MA, Rivolta D, Logroscino G. An update on the use of gamma (multi)sensory stimulation for Alzheimer's disease treatment. Front Aging Neurosci. 2022 Dec 15;14:1095081. doi: 10.3389/fnagi.2022.1095081. eCollection 2022.
• Lucey BP. It's complicated: The relationship between sleep and Alzheimer's disease in humans. Neurobiol Dis. 2020 Oct;144:105031. doi: 10.1016/j.nbd.2020.105031. Epub 2020 Jul 29.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2021
• Primary Completion (Actual): March 30, 2022
• Study Completion (Actual): December 30, 2022

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: adherence; insomnia; sleep quality; adverse effect; gamma sensory flicke
• Other Study ID Numbers: FirstShanxiMU_jsk

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will share individual participant data (including informed consent) after the study was published

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No