Insomnia
Conditions
Keywords
Insomnia, Intelligence Model, Prediction, Differential diagnosis and treatment, System
Brief summary
To establish a multicenter, multi-dimensional cohort on insomnia disorder and to develop an intelligent model for the diagnosis and treatment of insomnia disorder.
Detailed description
The study endeavors to establish a multicenter cohort comprising 16,000 individuals diagnosed with insomnia disorder, with a subsequent 2-year follow-up. Objectives encompass elucidating the natural development of insomnia disorder within diverse populations, identifying associated factors, and evaluating the short-term and long-term impacts on physiological, psychological, and social functions in insomnia disorder. Additionally, the research aims to devise early screening methodologies, precise assessments, and innovative disease classifications utilizing real-time assessment technology within the insomnia disorder cohort. Furthermore, the investigation seeks to ascertain graded diagnoses, treatment modalities, and prognostic indicators based on advanced multi-dimensional real-time assessment technology applied to a substantial insomnia disorder cohort. Finally, the study aims to refine remote interactive diagnostic and treatment modalities tailored to diverse age groups, culminating in developing a systematic graded diagnostic and treatment framework for insomnia disorder.
Interventions
Routine clinical treatment is based on the latest international guidelines for insomnia.
Sponsors
West China Hospital
Beijing Tiantan Hospital
Second Affiliated Hospital of Soochow University
Chifeng City Center Hospital Ningcheng County
Xuanwu Hospital, Beijing
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. A complaint of insomnia; 2. Age between 18 and 75; 3. Able to fill out the scale on their own; 4. Agree to sign the informed consent to participate in the study and cooperate in completing the follow-up visit.
Exclusion criteria
1.A current or history of comorbid Axis I psychiatric disorders.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of Pittsburgh Sleep Quality Index (PSQI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | The PSQI consists of 7 factors ranging from 0 to 3 points, and the total score ranges from 0 to 21 with higher scores indicating poorer quality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of Epworth Sleepiness Scale (ESS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | The ESS assessing daytime sleepiness consists of 8-items on a 4-point Likert scale, and the total score ranges from 0 to 24 with higher scores indicating more sleepiness. |
| The change of sleep onset latency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | Sleep onset latency is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer sleep onset latency). |
| The change of wake after sleep onset from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | Wake after sleep onset is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer wake after sleep onset). |
| The change of terminal wakefulness from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | Terminal wakefulness is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer terminal wakefulness). |
| The change of sleep efficiency from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | Sleep efficiency is assessed with the Carney (2012) consensus sleep diary. This is measured in percentage (higher scores indicating better sleep efficiency). |
| The change of total sleep time from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | Total sleep time is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer total sleep time). |
| The change of Dysfunctional Beliefs and Attitudes about Sleep Scale (DBAS) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | The DBAS assessing sleep related cognitions in 16 item rated on a 10-point Likert scale, and the total score ranges from 0 to 160 with higher scores indicating more intensive disfunctional beliefs. |
| The change of Insomnia severity index (ISI) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | The ISI reporting insomnia symptoms severity consists of 7-items on a 5-point Likert scale, and the total score ranges from 0 to 28 with higher scores indicating more severe insomnia. |
| The change of Short Form 36 (SF-36) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | The SF-36 quantifing the quality of life in relation to health status consists of 36-items with eight areas covering physical functioning, role limitations brought on by physical issues, bodily pain, general health perceptions, vitality, social functioning, role limitations brought on by emotional issues, and perceived mental health. The total score ranges from 0-100 (the worst possible to the most possible). |
| The change of PHQ-15 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | The PHQ-15 measuring somatic distress consists of 15 items, and the total score ranges from 0 to 30 with higher scores indicating more severe somatic distress. |
| The change of PDQ-D-5 total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | The PDQ-D-5 assessing perceived cognitive deficits from the patient's perspective consists of 5 items, and the total score ranges from 0 to 20 with higher scores indicating greater perceived deficit. |
| The change of SHAPS total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | The SHAPS assessing anhedonia consists of 14 items, and the total score ranges from 14 to 56 with higher scores indicating more serious the anhedonia. |
| The change of Life Events Scale (LES) total scores from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | The LES assessing the perceived stress and number of stressful life events experienced consists of 48 items which are classified into three dimensions: family life events (28 items), work and study events (13 items), and social events (7 items) with higher scores in LES perceived greater stressfulness. |
| The change of time in bed from baseline to 3 months, 6 months, 12 months, 18 months, and 24 months. | Baseline, 3 months, 6 months, 12 months, 18 months, 24 months | Time in bed is assessed with the Carney (2012) consensus sleep diary. This is measured in minutes (higher scores indicating longer time in bed). |
Countries
China
Contacts
Primary ContactHuang Wang, MD
Outcome results
None listed