Study on Gamma Sensory Flicker for Insomnia

Sleep Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06322524
• Other study ID #: FirstShanxiMU_jsk
• Status: Completed
• Start date: May 1, 2021
• Est. completion date: December 30, 2022

Study information

• Verified date: March 2024
• Source: The First Affiliated Hospital of Shanxi Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 30, 2022
• Est. primary completion date: March 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sleep Quality

Intervention

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

Locations

Country	Name	City	State
China	Yong Xu	Taiyuan	Shanxi

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Shanxi Medical University	Shanxi Medical University

Country where clinical trial is conducted

China, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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
Primary	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
Primary	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
Primary	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	pre-sleep efficiency.	Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography.	pre-intervention
Secondary	post-sleep efficiency.	Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography.	8 weeks