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 range
19 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.