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| Name | Class |
|---|---|
| Shanxi Medical University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gamma sensory flicker | Device | participants were exposed to flicker stimulation through a light and sound device, the flicker was 40 Hz. |
|
| 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 |
| 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. |
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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.
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yong Xu | Taiyuan | Shanxi | 030000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38195580 | Background | 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. | |
| 33795429 | 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. |
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We will share individual participant data (including informed consent) after the study was published
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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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 |
| 8 weeks |
| 30879788 | 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. |
| 36589536 | 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. |
| 32738506 | Result | 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. |
| D001523 |
| Mental Disorders |