Study for Pregnant Women With Insomnia Using Sleep Inducing Digital Sound Application

Seoul National University

Status: Active, not recruiting

Conditions: Pregnancy, Second Trimester; Insomnia; Pregnancy, First Trimester

Treatments: Device: Provides meaningless sound in application; Device: Provides Sleep hygiene education text in application; Device: Sleep inducing digital sound application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07266415

B-2501-950-302

Details and patient eligibility

About

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

Full description

Duration of study period (per participant): Screening period (0-1 week), Intervention period (2 weeks), Follow-up period (1 week, without digital application use). Patient needs to visit the site at least 1 time (Screening). Other procedures will be conducted online. First visit is before the screening period, mainly to on-board patients and to train patients for accurate usage of the digital application.

Enrollment: 30 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 3 patient groups, including a placebo group

Experimental group

Experimental group

Treatment:

Device: Sleep inducing digital sound application

Sham-controlled group

Sham Comparator group

Treatment:

Device: Provides meaningless sound in application

Control group

Placebo Comparator group

Description:

Sleep Hygiene Education in application

Treatment:

Device: Provides Sleep hygiene education text in application