A prospective randomized clinical trial to evaluate the safety and efficacy of SMD sleepdoc digital therapy devices used to quantitatively improve insomnia symptoms in patients diagnosed with non-organic insomnia
- Conditions
- Mental and behavioural disorders
- Registration Number
- KCT0008707
- Lead Sponsor
- SMDsolutions
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 54
1) Adults over 19 years of age
2) Diagnosis of nonorganic insomnia disorder (F51.0) of ICD-10 or sleep initiation and maintenance disorder by satisfying the criteria for diagnosis of nonorganic insomnia disorder of DSM-5 or the third edition of International Classification of Sleep Disorders , A person diagnosed with insomnia disorder (G47.0)
3) A person who satisfies 8 points or more on the Insomnia Disorder Severity Scale (ISI)
4) Those who have no difficulty in reading and writing Korean
5) Those who have no difficulty in using mobile applications using general-purpose equipment (smartphone or tablet PC, etc.)
6) A person who voluntarily decides to participate and agrees face-to-face to abide by the precautions after receiving and understanding sufficient explanations about this clinical trial
7) Android smartphone users
1) DSM-5 other sleep arousal disorders other than insomnia (hypersomnia, narcolepsy, breathing-related
Sleep disorder, circadian rhythm sleep arousal disorder, parasomnia) diagnosed
2) Those with insomnia due to physical illness or medications
3) A person with symptoms corresponding to a diagnosis of schizophrenia spectrum disorder, a diagnosis of bipolar disorder, or a person with symptoms corresponding to a major depressive episode at the time of basic evaluation
4) Has attempted suicide within the last 3 months, and committed suicide by a psychiatrist
Those who are judged to be in the high-risk group
5) Has there been any other cognitive-behavioral therapy that has been newly started or ongoing within the last 3 months
In this case, all other types of cognitive behavioral therapy, including insomnia, are included.
6) shift workers
7) Those with hearing impairment or cognitive impairment (e.g. dementia, etc.)
8) Those who have difficulty hearing, writing, and speaking Korean
9) Those who are contraindicated for sleep restriction treatment (pregnant women, students taking an exam, epilepsy, truck drivers or
Long-distance bus drivers, heavy machinery drivers, etc., whose daytime sleepiness can have fatal consequences)
10) Those who have difficulty using general-purpose equipment (smartphone or tablet PC, etc.)
11) Those who are judged by the investigator to be unsuitable for participation in clinical trials due to other reasons
12) Those who have changed the type and dose of drugs that directly affect sleep within the last 1 month
13) pregnant women
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean Insomnia Severity Scale (ISI) change in treatment group from pre-treatment
- Secondary Outcome Measures
Name Time Method Change in Mean Insomnia Severity Scale (ISI) from pre-treatment in the control group