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Preliminary clinical study on biomarkers shown in eletrooculogram during sleep in healthy adults

Preliminary clinical study on biomarkers shown in eletrooculogram during sleep in healthy adults

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009774
Enrollment
40
Registered
2024-09-09
Start date
2024-07-18
Completion date
Unknown
Last updated
2024-12-09

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

Dongguk University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Men and women aged 30 to 65 years old (Those in their 20s were excluded because they showed high variability in safety tests) (2) Those who completed the Pittsburgh Sleep Quality Index (PSQI) questionnaire (3) Those who voluntarily gave written consent to participate in this study

Exclusion criteria

Exclusion criteria: (1) Those diagnosed with the following sleep disorders or have the corresponding symptoms: - Moderate or higher level of snoring: A symptom in which the upper airway mucosa vibrates and makes noise due to partial closure of the upper airway during sleep, with an apnea-hypopnea index of less than 15 per hour of sleep - Sleep apnea: A decrease of more than 90% of the usual respiratory airflow for more than 10 seconds during sleep, occurring more than 15 times per hour - Moderate restless legs syndrome: A disease that causes sleep disturbance due to severe uncomfortable sensations in the legs, mainly before falling asleep, causing the legs to move - Periodic limb movement disorder: A sleep disorder in which parts of the body, including the limbs, move involuntarily and periodically during sleep - Narcolepsy: A disease in which sleepiness occurs episodicly during daily life (2) Those with a body mass index of 18 kg/m2 or less and 35 kg/m2 or more (3) Those with sensitive skin diseases, including contact skin diseases (4) Those receiving treatment for clinically significant physical diseases (severe infections, tumors, etc.) or mental illnesses (5) In addition to the above, if the clinical trial manager and person in charge determine that the subject is unsuitable for this trial

Design outcomes

Primary

MeasureTime frame
Sleep monitoring test (Eye movement signals using a sleep mask)

Secondary

MeasureTime frame
Pittsburgh Sleep Quality Index;Insomnia severity scale score;State-Trait Anxiety Inventory;Cold-heat Pattern Identification Questionnaires;Deficiency and Excess Pattern Identification Questionnaires;Heart rate variability;Pulse Waveform Measurement;Tongue imaging method

Countries

Korea, Republic of

Contacts

Public ContactKyungsun Han

Dongguk University Ilsan Oriental Hospital

khan@dumc.or.kr+82-31-961-9112

Outcome results

None listed

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