Post-traumatic Stress Disorder
Conditions
Interventions
At the P1 Unit of the University of Tokyo Hospital, under the supervision of an emergency response physician, PTSD patients are played trauma-recall sounds, which have been previously tested for their
D013016
Sponsors
Ino Keiko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Meets the diagnostic criteria for PTSD according to the PDS-5 Aged 18 years or older The attending psychiatrist at the primary care medical institution has granted permission to participate in this study Hearing is sufficiently preserved in both ears It is clinically anticipated that trauma memories can be recalled through sound.
Exclusion criteria
Exclusion criteria: The translation is: (1) Judged to have serious suicidal ideation (2) Suicide attempts or serious self-harm within the past 3 months (3) Has a history or concurrent condition of migraines triggered by sounds (4) Has a history or concurrent condition of epilepsy (5) Has a history or concurrent condition of serious acquired brain injury (ABI) (6) Diagnosed with schizophrenia spectrum disorders, other psychotic disorders, neurocognitive disorders, personality disorders, alcohol-related substance disorders, or exhibits manic episodes, by a psychiatrist during an interview (7) Has a history or concurrent condition of sleep apnea syndrome, periodic limb movement disorder, or restless legs syndrome (8) Has uncontrolled hypertension (systolic blood pressure consistently above 140mmHg or diastolic blood pressure above 90mmHg) (9) Has a serious physical illness that would interfere with the study (10) Insufficient understanding of Japanese (11) Anything else deemed inappropriate by the lead investigator or the responsible physician of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of study participants who were able to create sound and completed the sound stimulation during sleep. | — |
Secondary
| Measure | Time frame |
|---|---|
| The translation is: - The presence of serious adverse events or malfunctions (using a list extracted from CTCAE ver 5.0 for serious mental symptoms) - The proportion of patients who proceeded to create stimulus sounds and were able to create them - Changes in standardized scales before and after sound stimulation as preliminary indicators of effect (PCL-5, BDI-II, PSQI, SUDs during awake sound stimulation, etc.) - The real-time accuracy of sleep determination by the AI built into the device in patients with PTSD (especially the positive predictive value and sensitivity of slow-wave sleep, and the sensitivity and positive predictive value of awakening reactions) - The positive predictive value and sensitivity of sound stimulation executed during slow-wave sleep - The sleep structure in preliminary home-based sleep measurements and the sleep structure during overnight sound stimulation (determined by EEG) | — |
Contacts
Public ContactMasanori Sakaguchi
University of Tsukuba
Outcome results
None listed