Study on pupillary light reflex in diseases with circadian rhythm disorders

JRCT ID: jRCT1030230105

Registered date:02/06/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pupillary light reflex is measured in DSWPD, AD spetrum patients and Healthy controls
• Date of first enrollment: 02/06/2023
• Target sample size: 100
• Study type: Interventional
• Intervention(s): Measurement of post-illumination pupil response (PIPR): Red or blue LED light is presented for 1 second to subjects who have adapted to the dark.

Outcome(s)

• Primary Outcome: Comparison of PIPR among DSWPD patients, AD spectrum patients, and healthy controls
• Secondary Outcome: Contribution of individual factors (age, gender) to group differences in PIPR

Key inclusion & exclusion criteria

• Age minimum: >= 16age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

DSWPD patients: 1) Participants who are between 16 and 29 years old at the time of consent. 2) Participants who meet DSM-5 or ICSD-3 diagnostic criteria for DSWPD
Healthy controls of DSWPD patients: 1) Participants who are between 16 and 29 years old at the time of consent.
AD Spectrum Patients: 1) Participants who are between 60 and 80 years old at the time of consent. 2) Participants who meet the diagnostic criteria for AD Spectrum (Mild AD, MCI, Preclinical AD) 3) Participants who fully understand the study and give their free and voluntary written consent.
Healthy controls of AD spectrum patients: 1) Participants who are between 60 and 80 years old at the time of consent. 2) Participants who fully understand the study and give their free and voluntary written consent

Exclude criteria

DSWPD patients: 1) Participants with neurodegenerative diseases. 2) Participants with abnormal color vision. 3) Participants with darkness phobia. 4) Other subjects deemed inappropriate by the principal investigator.
Healthy controls of DSWPD: 1) Participants with psychiatric disorders. 2) Participants with neurodegenerative disorders. 3) Participants with abnormal color vision. 4) Participants with darkness phobia. 5) Other subjects deemed inappropriate by the principal investigator.
AD Spectrum Patients: 1) Participants with neurodegenerative diseases other than AD Spectrum. 2) Participants with abnormal color vision. 3) Those with darkness phobia. 4) Others whom the principal investigator deems inappropriate.
Healthy controls of AD spectrum: 1) Participants with psychiatric disorders. 2) Participants with neurodegenerative disorders. 3) Participants with abnormal color vision. 4) Participants with darkneess phobia. 5) Other subjects deemed inappropriate by the principal investigator.

Related Information

• Primary Sponsor: Kitamura Shingo
• Source(s) of Monetary Support: Japan Society for the Promotion of Science