Randomized controlled trial of a cognitive behavioral therapy application for insomnia (IIIP MED: Sleepy Med)

JRCT ID: jRCT2032230353

Registered date:21/09/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Insomnia disorder
• Date of first enrollment: 08/12/2023
• Target sample size: 30
• Study type: Interventional
• Intervention(s): Software as a Medical Device providing non-pharmacological treatment or sleeping pills for patients with insomnia disorder

Outcome(s)

• Primary Outcome: Change at 5 weeks from baseline in sSOL (subjective sleep onset latency)

Secondary Outcome

1) Change at 10 weeks from baseline in sSOL based on the participant's paper sleep diary

2) Change at 5 and 10 weeks from baseline in the following outcomes

Sleep-related outcomes
a) effect of sleep onset
-SOL (objective sleep latency) measured by mobile electroencephalography (EEG)
b) Effect of sleep maintenance
-sWASO (subjective wakefulness after sleep onset) based on the participant's paper sleep diary
-WASO (objective wakefulness after sleep onset) measured by mobile electroencephalography
-sNOA (subjective number of awakenings) based on the participant's paper sleep diary
-sSE (subjective sleep efficiency) based on the participant's paper sleep diary
-SE (objective sleep efficiency) measured by mobile electroencephalography
c) Total sleep time
-sTST (subjective total sleep time) based on the participant's paper sleep diary
-TST (objective total sleep time) measured by mobile electroencephalography
d)Sense of recovery after sleep
Feeling of sound sleep and feeling of refreshment

Functional improvement during the daytime (physical and mental functioning the next day)
(1)ISI (Insomnia Severity Index)
(2)KSS (Karolinska Sleepiness Scale)
(3)FSS (Fatigue Severity Scale)

Mental function and QOL
(1)GAD-7 (Generalized Anxiety Disorder-7)
(2)PHQ-9 (Patient Health Questionnaire-9)
(3)EQ-5D-5L (EuroQol 5 dimensions 5-level)
(4)DBAS-16 (Dysfunctional Beliefs and Attitudes About Sleep)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Screening step 1
(1) Age 18 years and older
(2) Meets DSM-5 diagnostic criteria for insomnia disorder
(3) ISI score >= 11
(4) Has internet access at home and can operate a smartphone or a tablet

Screening step 2
(1) Patients with subjective sleep onset latency (sSOL) of >= 30 minutes after keeping a sleep diary for at least 3 days
(2) Patients who have insomnia symptoms (ISI score >= 11) at 4 weeks after sleep hygiene education by a physician
(3) Patients who have not received pharmacotherapy or cognitive behavioral therapy for insomnia for 4 weeks at screening step 2

Exclude criteria

Screening step 1
(1) Patients with hypersomnolence disorder, narcolepsy, breathing-related sleep disorders, or parasomnias
(2) Patients with symptoms suspected of hypersomnolence disorder, narcolepsy, breathing-related sleep disorders, or parasomnias according to the investigator's or subinvestigator's clinical opinion
(3) Patients with moderate or higher anxiety symptoms (GAD-7 score >= 10)
(4) Patients with moderate or higher depressive symptoms (PHQ-9 >= 15)
(5) Patients with suicidal ideations (the ninth item of PHQ-9, suicidal ideation score >= 2 )
(6) Patients who habitually go to bed later than 2 am or wake up later than 10 am due to night shift
(7) Patients who are pregnant, breastfeeding (including discontinued breastfeeding), or planning a pregnancy during the study
(8) Patients who have been diagnosed by a medical institution as having alcohol or drug dependence within the past year (not including habitual smokers)
(9) Patients with any condition that may affect the safety of the subject or the conduct of this study (e.g., may affect sleep)
(10) Patients who are engaged in dangerous mechanical operations such as driving a car
(11) Patients who are currently participating in another clinical trial
(12) Patients who have received cognitive behavioral therapy for insomnia in the past
(13)Other patients who are judged by the investigator or sub investigator to be inappropriate to participate in this clinical trial.

Screening step 2
(1) Patients with the following diseases that the investigator or subinvestigator determines may affect the safety of the subject or the conduct of this clinical trial
(2) Other patients who are judged by the investigator or sub investigator to be inappropriate to participate in this clinical trial.

Related Information

• Primary Sponsor: Shimizu Eiji