InsomniaNCT05926531
Study on the Remote Diagnosis and Treatment Strategy of New-onset Insomnia Under the COVID-19 Epidemic
A study testing CBTI online programe in people with Insomnia and CBT, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Insomnia is a disorder characterized by both nocturnal and daytime symptoms. The main symptoms are unsatisfactory sleep quality or duration, accompanied by difficulty falling asleep before bedtime, frequent or prolonged awakenings, or an inability to fall back asleep after waking in the early morning. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Insomnia, CBT, Depression
- What is being tested?
- CBTI online programe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 15 May 2024
- Phase
- Interventional
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 1) meet the DSM-5 criteria for insomnia;
- 2) Insomnia severity index (ISI) ≥8;
- 3) Sleep Efficiency \< 85%;
- 4) aged 18-59 years;
- 5) can understand and adhere to the study protocol;
- 6) Informed consent can be signed online;
- 7) Have smart terminals (such as smart phones, tablets, computers, etc.) and know how to use wechat and VR devices.
Who cannot join
- 1) undiagnosed physical diseases, mental disorders and/or other chronic insomnia;
- 2) received psychotherapy for insomnia in the past month;
- 3) received medication for insomnia prescribed by a medical institution in the past month;
- 4) Frequent time-zone crossing;
- 5) those who are not comfortable with VR equipment;
- 6) those with suicidal ideation;
- 7) severe visual impairment, visual field defect, color blindness and visuospatial neglect; Nervous system disorders (sensory disorders, tremor, involuntary movement, Parkinson's disease, etc.).
Trial locations and contacts
1 site in 1 country.
About this study
Insomnia is a disorder characterized by both nocturnal and daytime symptoms. The main symptoms are unsatisfactory sleep quality or duration, accompanied by difficulty falling asleep before bedtime, frequent or prolonged awakenings, or an inability to fall back asleep after waking in the early morning. Our previous investigation has confirmed that during the period of home isolation of the epidemic, the community people suffered from acute insomnia induced by the epidemic. In order to comprehensively, efficiently and scientifically respond to major public health emergencies such as the COVID-19 epidemic and its long-term impact, it is necessary to carry out in-depth and systematic research on insomnia related issues of medical staff under the COVID-19 epidemic.
In summary, insomnia is a widespread problem among medical staff during the epidemic, which greatly reduces the work efficiency of medical staff and damages their physical and mental health. Without timely and effective early identification and effective intervention, allowing the disease to continue to develop will bring a series of concurrent diseases, threaten the lives of medical staff and bring a series of negative social effects. At the same time, the diagnosis and intervention of large-scale acute insomnia for medical staff under the epidemic face some scenario limitations, and it is necessary to consider the spread of the virus to reduce direct contact. Especially for some medical staff in isolation, it is more difficult to implement face-to-face evaluation, diagnosis and treatment. Under the COVID-19 pandemic, there are two main contradictions in the acute insomnia of medical staff. The first is the lack of a diagnostic cloud platform based on artificial intelligence for large-scale acute insomnia. The second is the lack of an effective remote intervention for acute insomnia suitable for the epidemic scenario.
Read more
Based on the results and deficiencies of the previous research, this project intends to further study and improve in three aspects. First, a large-scale and more accurate artificial intelligence-based automatic screening and diagnosis model research was carried out in combination with CPC equipment for acute insomnia screening of medical staff under the epidemic situation. The second is to use epidemic insomnia acute insomnia CPR to intervene the acute insomnia and other psychiatric symptoms of medical staff on a large scale and verify its effectiveness through follow-up. Third, for the epidemic scenario, further build an intelligent screening and remote intervention system platform for acute insomnia for the majority of medical staff, and continue to provide an assessment, intervention and consultation platform for medical staff under the epidemic.
Therefore, in order to comprehensively cope with the increase in the incidence of acute insomnia among medical staff under the COVID-19 epidemic and its resulting disease, social and economic burden, we should pay attention to the mental health of medical staff in the first-level key susceptible population, and improve the response experience of major public health emergencies in the future. This project aims to establish a portable and efficient artificial intelligent-based diagnosis cloud platform method and remote intervention system for medical staff with acute insomnia under the epidemic situation, which is suitable for large-scale development. Based on the data collected by portable devices and electronic scales, a risk assessment model for acute insomnia and other psychiatric symptoms of medical staff in the epidemic situation is constructed, and effective intervention is carried out on this basis. To promote the establishment of a comprehensive prevention and treatment system for insomnia after the epidemic, comprehensively carry out systematic work from multiple perspectives, improve mental health, summarize and form China's experience in dealing with major public emergencies, and promote it internationally, so as to reduce the impact and loss caused by the COVID-19 epidemic on a global scale.
- Conditions
- Insomnia, CBT, Depression, Anxiety
- Being tested
- CBTI online programe
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTI online programeDevice
Also called VR
20 MIN VR RELAX PROGRAME
| Study group | Role | What they receive |
|---|---|---|
| acute insomnia treatment group | Experimental | CBTI and VR intervention for one week Receives: Device: CBTI online programe |
| acute insomnia control group | No intervention | no intervention |
| chronic insomnia treatment group | Experimental | CBTI and VR intervention for one week Receives: Device: CBTI online programe |
| chronic insomnia control group | No intervention | no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluation of scale
insomnia severity index (ISI) score, more reduction mean better outcome
Measured: 7 days
Secondary outcomes (1)
total sleep time
total sleep time evaluaed by PSG
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start15 May 2023
- Primary completion15 May 2024 (estimated)
- Study completion15 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926531
- Sponsor's protocol ID
- NFEC-2023-085
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Remote Diagnosis and Treatment Strategy of New-onset Insomnia Under the COVID-19 Epidemic
- ClinicalTrials.gov ID
- NCT05926531
- Acronym / sponsor ID
- NFEC-2023-085
- Conditions
- Insomnia, CBT, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- 15 May 2023 (actual)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 15 May 2024 (estimated)
- First posted
- 3 Jul 2023 (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.
Insomnia is a disorder characterized by both nocturnal and daytime symptoms. The main symptoms are unsatisfactory sleep quality or duration, accompanied by difficulty falling asleep before bedtime, frequent or prolonged awakenings, or an inability to fall back asleep after waking in the early morning. Our previous investigation has confirmed that during the period of home isolation of the epidemic, the community people suffered from acute insomnia induced by the epidemic. In order to comprehensively, efficiently and scientifically respond to major public health emergencies such as the COVID-19 epidemic and its long-term impact, it is necessary to carry out in-depth and systematic research on insomnia related issues of medical staff under the COVID-19 epidemic.
In summary, insomnia is a widespread problem among medical staff during the epidemic, which greatly reduces the work efficiency of medical staff and damages their physical and mental health. Without timely and effective early identification and effective intervention, allowing the disease to continue to develop will bring a series of concurrent diseases, threaten the lives of medical staff and bring a series of negative social effects. At the same time, the diagnosis and intervention of large-scale acute insomnia for medical staff under the epidemic face some scenario limitations, and it is necessary to consider the spread of the virus to reduce direct contact. Especially for some medical staff in isolation, it is more difficult to implement face-to-face evaluation, diagnosis and treatment. Under the COVID-19 pandemic, there are two main contradictions in the acute insomnia of medical staff. The first is the lack of a diagnostic cloud platform based on artificial intelligence for large-scale acute insomnia. The second is the lack of an effective remote intervention for acute insomnia suitable for the epidemic scenario.
Based on the results and deficiencies of the previous research, this project intends to further study and improve in three aspects. First, a large-scale and more accurate artificial intelligence-based automatic screening and diagnosis model research was carried out in combination with CPC equipment for acute insomnia screening of medical staff under the epidemic situation. The second is to use epidemic insomnia acute insomnia CPR to intervene the acute insomnia and other psychiatric symptoms of medical staff on a large scale and verify its effectiveness through follow-up. Third, for the epidemic scenario, further build an intelligent screening and remote intervention system platform for acute insomnia for the majority of medical staff, and continue to provide an assessment, intervention and consultation platform for medical staff under the epidemic.
Therefore, in order to comprehensively cope with the increase in the incidence of acute insomnia among medical staff under the COVID-19 epidemic and its resulting disease, social and economic burden, we should pay attention to the mental health of medical staff in the first-level key susceptible population, and improve the response experience of major public health emergencies in the future. This project aims to establish a portable and efficient artificial intelligent-based diagnosis cloud platform method and remote intervention system for medical staff with acute insomnia under the epidemic situation, which is suitable for large-scale development. Based on the data collected by portable devices and electronic scales, a risk assessment model for acute insomnia and other psychiatric symptoms of medical staff in the epidemic situation is constructed, and effective intervention is carried out on this basis. To promote the establishment of a comprehensive prevention and treatment system for insomnia after the epidemic, comprehensively carry out systematic work from multiple perspectives, improve mental health, summarize and form China's experience in dealing with major public emergencies, and promote it internationally, so as to reduce the impact and loss caused by the COVID-19 epidemic on a global scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| acute insomnia treatment group | Experimental | Device: CBTI online programeCBTI and VR intervention for one week |
| acute insomnia control group | No intervention | –no intervention |
| chronic insomnia treatment group | Experimental | Device: CBTI online programeCBTI and VR intervention for one week |
| chronic insomnia control group | No intervention | –no intervention |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 1) meet the DSM-5 criteria for insomnia;
- 2) Insomnia severity index (ISI) ≥8;
- 3) Sleep Efficiency \< 85%;
- 4) aged 18-59 years;
- 5) can understand and adhere to the study protocol;
Key exclusion criteria (7 listed)
- 1) undiagnosed physical diseases, mental disorders and/or other chronic insomnia;
- 2) received psychotherapy for insomnia in the past month;
- 3) received medication for insomnia prescribed by a medical institution in the past month;
- 4) Frequent time-zone crossing;
- 5) those who are not comfortable with VR equipment;
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 |
|---|---|---|
| CBTI online programeAlso: VR20 MIN VR RELAX PROGRAME | Device | acute insomnia treatment group, chronic insomnia treatment group |
Primary outcome
evaluation of scale
Time frame: 7 days
insomnia severity index (ISI) score, more reduction mean better outcome
1 secondary outcome
total sleep time
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Individual participant dataSharing planned: No
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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?
A study testing CBTI online programe in people with Insomnia and CBT, run by Nanfang Hospital, Southern 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 7 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 3 Jul 2023. 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?
Results are not available in the source record.
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?
evaluation of scale (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jul 2023.