Study on Gamma Sensory Flicker for Insomnia

NCT06322524 | Completed DMC

• 1 other identifier: FirstShanxiMU_jsk
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Quality; Sleep Duration; Sleep Onset Latency

Keywords

gamma sensory flicke; insomnia; sleep quality; adherence; adverse effect

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (2)

• pre-sleep efficiency.

  pre-intervention

• post-sleep efficiency.

  8 weeks

Study Arms (1)

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

Interventions

Gamma sensory flicker DEVICE

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

insomnia group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Shanxi Medical University: lead
• Shanxi Medical University: collaborator

Study Sites (1)

Yong Xu

Taiyuan, Shanxi, 030000, China

Location

Related Publications (5)

• 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.

  PMID: 38195580 BACKGROUND

• 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.

  PMID: 33795429 BACKGROUND

• 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.

  PMID: 30879788 BACKGROUND

• 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.

  PMID: 36589536 BACKGROUND

• 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.

  PMID: 32738506 RESULT

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 21, 2024
• Study Start: May 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: December 30, 2022
• Last Updated: March 21, 2024

Record last verified: 2024-03

Locations

CN (1)