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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
30
Application: BELL-001
Sham application intervention
Placebo application
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Primary outcome measurement
Insomnia severity index
Time frame: 1 week
Sleep Latency (SL, Minutes), assessed using a sleep diary
Time frame: 1 week
Sleep Latency (SL, Minutes), assessed using a smartwatch
Time frame: 1 week
Sleep Efficiency (SE, Percentage), assessed using a sleep diary
Time frame: 1 week
Sleep Efficiency (SE, Percentage), assessed using a smartwatch
Time frame: 1 week
Wake After Sleep Onset (WASO, Minutes), assessed using a sleep diary
Time frame: 1 week
Wake After Sleep Onset (WASO, Minutes), assessed using a smartwatch
Time frame: 1 week
Total Sleep Time (TST, Minutes), assessed using a sleep diary
Time frame: 1 week
Total Sleep Time (TST, Minutes), assessed using a smartwatch
Time frame: 1 week
Sleep Quality (SQ, Score 1-10; bad-good), assessed using a sleep diary
Time frame: 1 week
Pittsburgh Sleep Quality Index (PSQI, Score 0-21; better-worse)
Time frame: 2 weeks
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Edinburgh Postnatal Depression Scale (EPDS, Score 0-30; better-worse)
Time frame: 2 weeks
Generalized Anxiety Disorder-7 (GAD-7, Score 0-21; better-worse)
Time frame: 2 weeks
Pregnancy-Related Anxiety Questionnaire (PRAQ, Score 32-128; better-worse)
Time frame: 2 weeks