Study for Pregnant Women With Insomnia Using Sleep Inducing Digital Sound Application (NCT07266415) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Study for Pregnant Women With Insomnia Using Sleep Inducing Digital Sound Application
South Korea30 participantsStarted 2025-06-24
Plain-language summary
This study aims to evaluate the safety and efficacy of sleep inducing digital sound application on pregnant women in their 1st and 2nd trimester with insomnia
Who can participate
Age range19 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 19 years older
* pregnant women in their 1st and 2nd trimester
* suffering from insomnia symptom
* scored 10 or high in screening ISI
* a person who voluntarily agreed to participate in this RCT
Exclusion Criteria:
* Has a confirmed diagnosis of insomnia disorder other than chronic insomnia based on DSM-5(ex. Narcolepsy, Periodic Limb Movement, Restless Leg syndrome, etc)
* Has a confirmed diagnosis of other neuropsychiatric disease
* Has an history of suicidal ideat or attempt
* Shift worker
* Going through other interventions regarding insomnia(sleeping pills, light therapy, other alternative interventions)
* Has a severe auditory, visual, or cognitive impairment
* A person who cannot familiarize with the usage of smartphones and digital applications
* Has a history of alcohol or other substance use disorder
* A person with high risk pregnancy considered inadequate to participate in this trial by obstetric experts
* A person considered inadequate to participate in this trial by a clinical expert