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Validity Evaluation of Eye Patch-Type Bio-signal Measuring Device for Sleep Monitoring: A Comparative Study with Polysomnography

Validity Evaluation of Eye Patch-Type Bio-signal Measuring Device for Sleep Monitoring: A Comparative Study with Polysomnography

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0010101
Enrollment
45
Registered
2025-01-03
Start date
2025-01-27
Completion date
Unknown
Last updated
2025-01-06

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

Conditions

None listed

Interventions

None listed

Sponsors

Daejeon Korean Medicine Hospital of Daejeon University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Men and women between 19 and 60 years of age 2. Those who score 8 or more on the Insomnia Severity Scale (ISI) 3. Individuals who voluntarily decide to participate after receiving and understanding a sufficient explanation of this clinical trial and agree in writing to comply with the precautions.

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with parasomnias (e.g., sleepwalking, night terrors, REM sleep behavior disorder, or other disruptive sleep-related behaviors) 2. Individuals who have taken medication for a psychiatric illness other than insomnia within the past 3 months 3. Those using positive airway pressure 4. Individuals unsuitable for testing due to congenital deformities, abnormalities, etc. 5. Individuals with claustrophobia or who have been diagnosed with claustrophobia 6. Persons at high risk of falling due to mobility impairment 7. Other cases where clinical research personnel determine that participation is not appropriate.

Design outcomes

Primary

MeasureTime frame
Eye Movement

Secondary

MeasureTime frame
Heart Rate;Oxygen Saturation (SpO2);Pattern Identifications Tool for Insomnia;ISI (Insomnia Severity Index);PSQI (Pittsburgh Sleep Quality Index);K-ESS (Korean Epworth Sleepiness Scale);HADS (Hospital Anxiety and Depression Scale)

Countries

Korea, Republic of

Contacts

Public ContactIn Chul Jeong

Daejeon Korean Medicine Hospital of Daejeon University

npjeong@daum.net+82-42-470-9544

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026