Sound exposure therapy during sleep for PTSD

JRCT ID: jRCT1030230706

Registered date:15/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Post-traumatic Stress Disorder
• Date of first enrollment: 15/03/2024
• Target sample size: 6
• Study type: Interventional

Intervention(s)

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 reaction, through earphones during sleep. A sleep assessment person in the observation room will real-time determine the slow-wave sleep (criteria: more than 6 slow-wave activities (0.5-2Hz & peak-to-peak amplitude >75uV) within a 30-second interval judgment window) and the arousal response at the time of sound occurrence (such as newly emerged significant alpha waves) while viewing the EEG screen displayed remotely on a PC. When slow-wave sleep is detected continuously for more than 90 seconds (confirming stable slow-wave sleep), the sound set in the sound generator in advance is played. If an arousal response is observed during this, the sound is temporarily stopped. The sound stimulus gradually increases from silence to a maximum of 40db and uses a sound that makes the patient's fear level (SUDs) 30-40 when hearing it. If the patient transitions to a wakefulness or a sleep stage other than slow-wave sleep due to the sound stimulus, the sound stimulus is temporarily stopped. Each time the sound stimulus starts, it is designed to gradually increase in volume from silence. The sound stimulus is limited to a maximum of 10 minutes per night. If more than 50% arousal response occurs within 30 seconds after the start of the sound stimulus or arousal with PTSD-related symptoms is observed, the sound stimulus is promptly stopped.

During both wakefulness and sleep, changes in skin conductance response and pulse wave (heart rate) in response to the sound stimulus are measured and recorded.

Outcome(s)

• Primary Outcome: The proportion of study participants who were able to create sound and completed the sound stimulation during sleep.

Secondary Outcome

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)

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Ino Keiko
• Secondary Sponsor: Sakaguchi Masanori
• Source(s) of Monetary Support: Takeda Science Foundation,Japan Agency for Medical Research and Development (AMED),Japan Society for the Promotion of Science (JSPS)