Insomnia, Pregnancy, First Trimester, Pregnancy, Second Trimester
Conditions
Keywords
insomnia, pregnancy
Brief 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
Detailed 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.
Interventions
DEVICESleep inducing digital sound application
Application: BELL-001
DEVICEProvides meaningless sound in application
Sham application intervention
DEVICEProvides Sleep hygiene education text in application
Placebo application
Sponsors
BELL Therapeutics Inc.
Seoul National University Bundang Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary outcome measurement | 1 week | Insomnia severity index |
Secondary
| Measure | Time frame |
|---|---|
| Sleep Latency (SL, Minutes), assessed using a sleep diary | 1 week |
| Sleep Latency (SL, Minutes), assessed using a smartwatch | 1 week |
| Sleep Efficiency (SE, Percentage), assessed using a sleep diary | 1 week |
| Sleep Efficiency (SE, Percentage), assessed using a smartwatch | 1 week |
| Wake After Sleep Onset (WASO, Minutes), assessed using a sleep diary | 1 week |
| Wake After Sleep Onset (WASO, Minutes), assessed using a smartwatch | 1 week |
| Total Sleep Time (TST, Minutes), assessed using a sleep diary | 1 week |
| Total Sleep Time (TST, Minutes), assessed using a smartwatch | 1 week |
| Sleep Quality (SQ, Score 1-10; bad-good), assessed using a sleep diary | 1 week |
| Pittsburgh Sleep Quality Index (PSQI, Score 0-21; better-worse) | 2 weeks |
| Edinburgh Postnatal Depression Scale (EPDS, Score 0-30; better-worse) | 2 weeks |
| Generalized Anxiety Disorder-7 (GAD-7, Score 0-21; better-worse) | 2 weeks |
| Pregnancy-Related Anxiety Questionnaire (PRAQ, Score 32-128; better-worse) | 2 weeks |
Countries
South Korea
Outcome results
None listed