Primary Insomnia
Conditions
Interventions
Gold Standard:PSG/polysomnography
Index test:Five Seasons Sleep Mat
Sponsors
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
0.5 Years to 18 Years
Inclusion criteria
Inclusion criteria: Part One:Evaluation of Optimized Five-Season Sleep Mats for Children's Insomnia 1. Age: Children and adolescents aged 6 months to 18 years; 2. Health status: Healthy, primary insomnia, ASD with insomnia, ADHD with insomnia, depression with insomnia. (1) Healthy: Full-term birth (>= 37 weeks and = 2.5 kg; no congenital birth defects, no postnatal asphyxia or resuscitation, and never transferred to a neonatal or intensive care unit; weight-for-age z-score, height-for-age z-score, or weight-for-height z-score between -2 and 2 (according to WHO standards); no active illness (such as fever, pneumonia, etc.), no chronic physical (such as asthma, hypertension, etc.), chronic developmental or mental diseases (such as autism, ADHD, depression, etc.). (2) Primary insomnia: Based on being healthy, sleep latency > 30 minutes, or sleep dependency (nursing to sleep, being held to sleep, rocking to sleep, etc.), or more than 1 nighttime awakening, or awakenings lasting more than 20 minutes. At least one of the above sleep problems occurs 3 days per week, persisting for 3 months or more. (3) ASD with insomnia: Based on primary insomnia, meeting clinical diagnosis of ASD. (4) ADHD with insomnia: Based on primary insomnia, meeting clinical diagnosis of ADHD. (5) Depression with insomnia: Based on primary insomnia, meeting clinical diagnosis of mild to moderate depression. 3. Sleeping arrangement: Independent sleep, co-sleeping (sleeping the entire night with parents or others on the same bed, with at least 1 person). Part Two:Multicenter Evaluation of the Five-Season Sleep Mat for Children's Insomnia 1. Age: Children and adolescents aged 6 months to 18 years; 2. Presence of insomnia problems: Sleep latency > 30 minutes, or sleep dependency (nursing to sleep, being held to sleep, rocking to sleep, etc.), or more than 1 nighttime awakening, or awakenings lasting more than 20 minutes. At least one of the above sleep problems occurs 3 days per week, persisting for 3 months or more. 3. Developmental and mental disorders: With or without, all are included.
Exclusion criteria
Exclusion criteria: None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| night waking;waking time;daytime sleepiness;sleep onset latency; | — |
Secondary
| Measure | Time frame |
|---|---|
| The validity (accuracy) of key indicators;The reliability (consistency) of key indicators; | — |
Countries
China
Contacts
Public ContactQINGMIN LIN
Shanghai Children's Medical Center, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed