Insomnia
Conditions
Interventions
trail B group:CES plus Pink noise added to CBTI
trail A group:CES plus double beat added to CBTI
Sponsors
The First Hospital of Jilin University
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1) Age range between 18 and 60 at the time of signing the informed consent form. 2) First time receiving treatment for insomnia and meeting the criteria for insomnia disorders in the Diagnostic and Statistical Manual of Mental Disorders, DSM-5. Following that: - Night sleep dissatisfaction, difficulty falling/maintaining sleep and/or waking early (earlier than expected) despite adequate sleep opportunities. - Frequency := 3 times a week - Duration: = 3 months - Daytime impairment 3) sSOL = 30 minutes within 45-75 minutes and ISI score of 8-21 (mild to moderate insomnia) on at least 3 nights per week during the 4 weeks prior to the start of the trial. 4) Self-reported regular bed time (sleeping or trying to fall asleep) is =7 and = 9 hours. 5)According to the answers in the sleep diary of the last 7 mornings before the screening period(i.e. SOL = 30 minutes on at least 3 of the 7 nights),the current insomnia symptoms were confirmed. 6) According to the answers in the sleep diary of the last 7 mornings before the visit (e.g. bed rest duration 10 hours for no more than 2 nights), it is confirmed that there is enough bed rest time. 7) The objective (Huawei bracelet) evidence of insomnia in the last seven days before the visit is as follows: SOL = 30 minutes on two consecutive nights or more than three nights and SOL is not less than 20 minutes on two nights. 8) The subject is willing and able to comply with all aspects of the protocol, including the time of staying in bed= 7 hours per night. 9) During the study period, the subject agree not to use new drugs therapy or other physical therapy.
Exclusion criteria
Exclusion criteria: 1)History of medical or psychiatric disorders that the investigator believes could affect the safety of the subject or interfere with the evaluation of the study. 2)Planned or unplanned suicidal ideation at or within 6 months of screening. 3)Any suicidal behavior within the past 10 years. 4)Clinically significant diseases(e.g. heart disease, respiratory system disease, including chronic obstructive pulmonary disease, acute and / or severe respiratory depression; gastrointestinal diseases; severe liver damage; kidney disease, including moderate and/or severe kidney damage; nervous system disease, including myasthenia gravis; mental disease; or a history of malignancy within the past 5 years, except for well-treated basal cell carcinoma) or chronic pain that the investigator considers may affect the safety of the subject or interfere with the evaluation of the study. Due to the subject's occupation or activity, subjects who prohibited sedative drugs for safety reasons were also excluded. Surgery planned during the study. 5)History of drug or alcohol dependence or abuse within around past 2 years. 6)Sleep-related breathing disorders currently diagnosed includeobstructive sleep apnea(treatment with or without continuous positive airway pressure (CPAP))Periodic Limb DyskinesiaRestless leg syndromecircadian sleep disorder or narcolepsy. 7)Self-reported history of sleep-related violence, or sleep-driving or any other complex sleep-related behavior(for example, making phone calls or preparing and eating food while sleeping). 8)Habitual daytime naps=3 times per week. 9)The researchers believe that excessive caffeine causes insomnia, so the subject that habitually consumes caffeinated beverages after 18:00, and is unwilling to refuse caffeine after 18:00 during the study period will be excluded. Besides, the subject who meets the following criteria is excluded,and the criteria include: If the symptoms meet DSM-5 caffeine poisoning standard in the past 3 months, including consuming a lot of caffeine (=250mg), and more than 5 symptoms: restlessness, nervousness, excitement, insomnia, facial Flushing, polyuria, gastrointestinal disturbances, muscle twitching, confusion in thought and speech, tachycardia or arrhythmia, high energy or psychomotor agitation. In order to be exclusive, these symptoms must cause distress or damage to society, occupation and other functions, and not related to other substances, mental disorders, or medical illnesses. 10)Self-reported daily alcoholic beverages consumption > 14 cups (female) or 21 cups (male) per week or unwillingness to limit alcohol intake during participation in the study(No more than 2 cups per day, or no alcohol intake within 3 hours before bedtime) 11)Comorbid nocturia, which can cause or aggravate insomnia. 12)Inter-time zone travel across more than 3 time zones in the 2 weeks prior to screening or between screening and baseline, or planning to travel through more than 3 time zones during the study(Mainland China will be considered as 1 time zone). 13)The subject has positive drug test results at screening, lead-in, or baseline, or are unwilling to abstain from recreational drug use during the study. 14)In 30 days prior to signing the informed consent form, participating in another clinical trial or using any experimental drug or device. Women who were breastfeeding or pregnant are excluded at screening or baseline (proven by a positive beta-human chorionic gonadotropin [ßhCG] test). 15)Women who are
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SOL; | — |
Secondary
| Measure | Time frame |
|---|---|
| PQSI;TST;SE; | — |
Countries
China
Contacts
Public Contactlvyudan
The First Hospital of Jilin University
Outcome results
None listed