Sleep Duration, Sleep Onset Latency, Sleep Quality
Conditions
Keywords
gamma sensory flicke, insomnia, sleep quality, adherence, adverse effect
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.
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.
Interventions
DEVICEGamma sensory flicker
participants were exposed to flicker stimulation through a light and sound device, the flicker was 40 Hz.
Sponsors
Shanxi Medical University
The First Affiliated Hospital of Shanxi Medical University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in awakening times between the first and eighth weeks | 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. |
| Differences in sleep duration between the first and eighth weeks | 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. |
| Differences in sleep onset latencies between the first and eighth weeks | 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. |
| Treatment adherence rate | 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% |
| Patient treatment adherence rate | 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% |
| Incidence rate of adverse reaction | 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% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| post-sleep efficiency. | 8 weeks | Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography. |
| pre-sleep efficiency. | pre-intervention | Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography. |
Countries
China
Outcome results
None listed