Sleep QualityNCT06322524

Study on Gamma Sensory Flicker for Insomnia

An observational study of Sleep Quality and Sleep Duration, run by The First Affiliated Hospital of Shanxi Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Sleep Quality, Sleep Duration, Sleep Onset Latency
What is being tested?: Gamma sensory flicker
Type of treatment: Medical device
How many people: 37 participants
Where: 1 siteChina
Study dates: 1 May 2021to 30 Dec 2022
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Yong Xu
Taiyuan, Shanxi, 030000

Other trials in China

About this study

Official title: 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.

Read the detailed description

A total of 37 participants underwent polysomnography (PSG) prior to the commencement of the study.

Conditions: Sleep Quality, Sleep Duration, Sleep Onset Latency
Being tested: Gamma sensory flicker
Keywords: gamma sensory flicke, insomnia, sleep quality, adherence, adverse effect
Medical subject headings: Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06322524
Study group	Role	What they receive
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. Receives: Device: Gamma sensory flicker

What is being measured

The primary outcome is the main question the study is designed to answer.

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%
Measured: 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%
Measured: 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%
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks

Secondary outcomes (2)

pre-sleep efficiency.
Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography.
Measured: pre-intervention
post-sleep efficiency.
Sleep efficiency=total sleep time/total bed rest time x 100% according to the Polysomnography.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202130 Dec 2022

First posted21 Mar 2024
Study start1 May 2021
Primary completion30 Mar 2022
Study completion30 Dec 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Sleep QualityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06322524
Sponsor's protocol ID: FirstShanxiMU_jsk
Status last verified: Mar 2024
First submitted: 5 Mar 2024
Last updated: 21 Mar 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: We will share individual participant data (including informed consent) after the study was published

Publications

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.
PubMed 38195580
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.
PubMed 33795429
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.
PubMed 30879788
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.
PubMed 36589536
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.
PubMed 32738506

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Shanxi Key Laboratory of Artificial Intelligence Assisted Diagnosis and Treatment for Mental Disorder
ClinicalTrials.gov ID: NCT06322524
Acronym / sponsor ID: FirstShanxiMU_jsk
Conditions: Sleep Quality, Sleep Duration, Sleep Onset Latency
Keywords: gamma sensory flicke, insomnia, sleep quality, adherence, adverse effect
Study type: Observational
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: The First Affiliated Hospital of Shanxi Medical UniversityUniversity, hospital or other
Collaborators: Shanxi Medical University
Study start: 1 May 2021 (actual)
Primary completion: 30 Mar 2022 (actual)
Study completion: 30 Dec 2022 (actual)
First posted: 21 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

A total of 37 participants underwent polysomnography (PSG) prior to the commencement of the study.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
insomnia group	–	Device: Gamma sensory flickerinsomnia 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.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Gamma sensory flickerparticipants were exposed to flicker stimulation through a light and sound device, the flicker was 40 Hz.	Device	insomnia group

Primary outcome

Treatment adherence rate
Time frame: 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
Time frame: 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
Time frame: 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%
Differences in sleep duration between the first and eighth weeks
Time frame: 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
Time frame: 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.
Differences in awakening times between the first and eighth weeks
Time frame: 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.

2 secondary outcomes

pre-sleep efficiency.
Time frame: pre-intervention
post-sleep efficiency.
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
Background: PubMed 38195580Son 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.
Background: PubMed 33795429Fernandez-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.
Background: PubMed 30879788Martorell 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.
Background: PubMed 36589536Manippa 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.
Results publication: PubMed 32738506Lucey 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.
Individual participant dataSharing planned: Undecided. We will share individual participant data (including informed consent) after the study was published

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Sleep Quality and Sleep Duration, run by The First Affiliated Hospital of Shanxi Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment adherence rate (time frame: 8 weeks （56 days）). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06322524, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.