A Pilot Study to Evaluate the Efficacy and Safety of the Circadian Rhythm for Sleep (CRS) Application for Improving Insomnia

A Pilot Study to Evaluate the Efficacy and Safety of the Mobile Application Circadian Rhythm for Sleep (CRS) in Improving Sleep Among Individuals with Insomnia

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0010801

Enrollment

Registered

2025-07-23

Start date

2024-02-01

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Behavioral, Others(Digital Therapeutics (Mobile Applicatinon)) : 1. Participants wore a Fitbit device continuously for 24 hours a day over a six-week period and completed a daily survey by launching t

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Individuals aged 19 years or older (2) Diagnosed with acute or chronic insomnia according to the International Classification of Sleep Disorders, Third Edition (ICSD-3) (3) Scored 8 or higher on the Insomnia Severity Index (ISI) (4) Users of Android smartphones with OS version 7.0 or higher (5) Individuals who voluntarily decided to participate in the clinical trial and provided written informed consent after receiving a detailed explanation (6) Individuals willing to comply with the study protocol

Exclusion criteria

Exclusion criteria: (1) Individuals diagnosed with other sleep disorders such as sleep apnea or restless legs syndrome based on DSM-5 or ICSD-3 criteria (2) Individuals with insomnia caused by physical illnesses such as cardiovascular disease (e.g., heart failure, angina, myocardial infarction, arrhythmia), malignancy, severe renal or hepatic dysfunction, endocrine, gastrointestinal, or pulmonary diseases (3) Individuals whose underlying medical conditions may worsen with sleep restriction (e.g., psychosis, bipolar disorder) (4) Individuals scoring 10 or higher on the Patient Health Questionnaire-9 (PHQ-9), indicating moderate or greater depressive symptoms (5) Individuals with a history of serious neurological disorders such as head trauma or seizure disorders (6) Individuals with insomnia attributable to medications (e.g., stimulatory chronic disease treatments) or lifestyle habits (e.g., excessive caffeine intake, heavy smoking or alcohol use) (7) Individuals whose schedules make participation in sleep interventions difficult (e.g., night shift workers, rotating shift workers) (8) Individuals with visual, auditory, or cognitive impairments that interfere with the use of the clinical trial app (9) Individuals unable to use smartphones or wearable devices (10) Individuals unable to complete the CRS app’s daily sleep satisfaction survey (11) Pregnant or breastfeeding individuals (12) Any other individuals deemed inappropriate for participation by the investigator due to ethical concerns or potential impacts on study outcomes

Design outcomes

Primary

Measure	Time frame
Insomnia Severity Index,;Pittsburgh Sleep Quality Index	—

Secondary

Measure	Time frame
Epworth Sleepiness Scale;WHOQOL-BREF;Composite Scale of Morningness	—

Countries

Korea, Republic of

Contacts

Public ContactHeon-Jeong Lee

Korea University Anam Hospital

leehjeong4@gmail.com+82-2-920-5507

Outcome results