The standardization of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders: a study of reliability and validity relevant to the measurement of treatment response

The standardization of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders: a study of reliability and validity relevant to the measurement of treatment response - The measurement of treatment response with the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000044683

Enrollment

100

Registered

2021-07-01

Start date

2023-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Circadian rhythm sleep-wake disorder

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients who were fully informed and gave written consent voluntarily with sufficient understandi ng. 2. >= 15 and < 75 years old and h aving graduated from a junior highschool at the consent 3. With a diagnosis of delayed sle ep-wake phase disorder, non-24-h our sleep-wake rhythm disorder, or irregular sleep-wake rhythm disorder according to International Classification of Sleep Disorders, 3rd edition(ICSD-3), including patients whose symptoms had remitted after treatment 4.Psychiatric and/or physical comorbidities are allowed 5. No restriction as to the ongoing treatments

Exclusion criteria

Exclusion criteria: 1. Shiftwork disorder or Jet lag disorder according to ICSD-3 2. Those who are judged inappropriate by a researcher in this stu dy for some other reason

Design outcomes

Primary

Measure	Time frame
Correlations between the change of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders and that of CGI-S	—

Secondary

Measure	Time frame
Inter-rater reliability of the Scale f or Symptom Severity of Circadian Sleep-Wake Rhythm Disorders Internal consistency of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders Factorial structure of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders Criterion validity of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders with regards to other questionnaires, DLMO, and actigraphic parameters Correlations between the change of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders and those of other questionnaires, DLMO, and actigraphic parameters	—

Measure

Time frame

Inter-rater reliability of the Scale f or Symptom Severity of Circadian Sleep-Wake Rhythm Disorders Internal consistency of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders Factorial structure of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders Criterion validity of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders with regards to other questionnaires, DLMO, and actigraphic parameters Correlations between the change of the Scale for Symptom Severity of Circadian Sleep-Wake Rhythm Disorders and those of other questionnaires, DLMO, and actigraphic parameters

—

Countries

Japan

Contacts

Public ContactTSUYOSHI KITAJIMA

Fujita Health University, School of Medicine Department of Psychiatry

tsuyoshi@fujita-hu.ac.jp0562-93-9250

Outcome results