Schizophrenia Schizophrenia
Conditions
Interventions
Participants will undergo overnight sleep recording with a portable EEG device. For a subset of participants, standard polysomnography (PSG) will also be performed on the same night, and the results w
D004569
Electroencephalography
Sponsors
Mizuki Satoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Schizophrenia Group Participants who meet all of the following criteria will be included: Individuals diagnosed with schizophrenia. Male or female outpatients aged between 18 and 65 years at the time of consent, who are attending Kurume University Hospital, Oshima Clinic, Shimonoseki Hospital, or Kato Hospital, which are collaborating institutions. Individuals who can understand the contents of the informed consent document, and from whom written informed consent is voluntarily obtained from the participant and/or a legally authorized representative.
Exclusion criteria
Exclusion criteria: Schizophrenia Group Participants who meet any of the following criteria will be excluded: 1. Individuals whose psychotropic medication has been changed within the past 4 weeks. 2. Individuals who have used benzodiazepine or non-benzodiazepine hypnotics within the past 2 weeks. 3. Individuals with a pacemaker. 4. Pregnant women, women who may be pregnant, or women who intend to become pregnant during the study period. 5. Individuals whose primary diagnosis is a psychiatric disorder other than schizophrenia. 6. Individuals with comorbid organic brain disease confirmed by CT or MRI. 7. Individuals with comorbid epilepsy. 8. Individuals suspected of having severe sleep apnea syndrome comorbid with psychiatric disorder. 9. Individuals with markedly irregular sleep-wake patterns. 10. Individuals with suicidal ideation or suicide attempts. 11. Individuals with a history of substance use disorder. 12. Individuals who are regularly prescribed opioid drugs, modafinil, steroids, or interferon. 13. Individuals with severe comorbid physical illness. 14. Individuals who are currently participating in another clinical trial, or who plan to participate in another trial during the study period. 15. Any other individuals deemed inappropriate as study participants by the principal investigator or sub-investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reproducibility of quantitative indices (Step 1) Spindle activity indices: - Occurrence frequency (/h): number of detected spindles / total sleep time - Detection time (sec): total duration of detected spindles - Duration (ms): detection time / number of spindles - Mean amplitude (uV): mean instantaneous amplitude per frequency during spindle duration Statistical analysis: ICC(2,1) and Bland-Altman method (bias +/- LoA) Passing criteria: ICC >= 0.75 and LoA within +/- 2 spindles/min 2. Detection of group differences (Step 2) Indices: the above quantitative spindle indices will be compared between healthy controls and schizophrenia groups (treated / drug-naive) Statistical methods: t-test / Mann-Whitney U test + ANCOVA adjustment Reporting: adjusted mean difference, p-values, effect size, and 95% confidence intervals | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. General sleep parameters Total sleep time, wake after sleep onset, sleep efficiency, sleep latency, etc. Occurrence rate and duration of each sleep stage N1, N2, N3, N4, REM 2. Clinical symptom scales Total score of the Brief Psychiatric Rating Scale BPRS | — |
Contacts
Public ContactSatoshi Mizuki
Department of Neuropsychiatry, Kurume University School of Medicine, Kurume, Japan
Outcome results
None listed