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Study on the Remote Diagnosis and Treatment Strategy of New-onset Insomnia Under the COVID-19 Epidemic

Primary Purpose

Insomnia, CBT, Depression

Status
Enrolling by invitation
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
CBTI online programe
Sponsored by
Nanfang Hospital, Southern Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.).

Sites / Locations

  • Nanfang Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

No Intervention

Experimental

No Intervention

Arm Label

acute insomnia treatment group

acute insomnia control group

chronic insomnia treatment group

chronic insomnia control group

Arm Description

CBTI and VR intervention for one week

no intervention

CBTI and VR intervention for one week

no intervention

Outcomes

Primary Outcome Measures

evaluation of scale
insomnia severity index (ISI) score, more reduction mean better outcome

Secondary Outcome Measures

total sleep time
total sleep time evaluaed by PSG

Full Information

First Posted
June 29, 2023
Last Updated
June 29, 2023
Sponsor
Nanfang Hospital, Southern Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05926531
Brief Title
Study on the Remote Diagnosis and Treatment Strategy of New-onset Insomnia Under the COVID-19 Epidemic
Official Title
Study on the Remote Diagnosis and Treatment Strategy of New-onset Insomnia Under the COVID-19 Epidemic
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 15, 2023 (Actual)
Primary Completion Date
May 15, 2024 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanfang Hospital, Southern Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, CBT, Depression, Anxiety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
acute insomnia treatment group
Arm Type
Experimental
Arm Description
CBTI and VR intervention for one week
Arm Title
acute insomnia control group
Arm Type
No Intervention
Arm Description
no intervention
Arm Title
chronic insomnia treatment group
Arm Type
Experimental
Arm Description
CBTI and VR intervention for one week
Arm Title
chronic insomnia control group
Arm Type
No Intervention
Arm Description
no intervention
Intervention Type
Device
Intervention Name(s)
CBTI online programe
Other Intervention Name(s)
VR
Intervention Description
20 MIN VR RELAX PROGRAME
Primary Outcome Measure Information:
Title
evaluation of scale
Description
insomnia severity index (ISI) score, more reduction mean better outcome
Time Frame
7 days
Secondary Outcome Measure Information:
Title
total sleep time
Description
total sleep time evaluaed by PSG
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.).
Facility Information:
Facility Name
Nanfang Hospital
City
Guangzhou
State/Province
Guangdong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study on the Remote Diagnosis and Treatment Strategy of New-onset Insomnia Under the COVID-19 Epidemic

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