KCT0008707
Terminated
未知
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
SMDsolutions0 sites54 target enrollmentTBD
ConditionsMental and behavioural disorders
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Mental and behavioural disorders
- Sponsor
- SMDsolutions
- Enrollment
- 54
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.)
Outcomes
Primary Outcomes
Not specified
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