RBD diagnostic research

JRCT ID: jRCTs032230718

Registered date:19/03/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with clinically suspected RBD
• Date of first enrollment: 19/03/2024
• Target sample size: 115
• Study type: Interventional
• Intervention(s): Analysis of sleep EEG, oclular/trunkal/extremities movements with InSomnoGraf M2, Nemuri-Scan, and conventional polysomnography

Outcome(s)

• Primary Outcome: The sensitivity of RBD diagnosis using InSomnoGraph M2 was determined with PSG-based RBD diagnosis (as defined by the criteria of the International Classification of Sleep Disorders, diagnosed when chin electromyographic activity exceeds 27% of REM sleep epochs determined in 30-second intervals) considered as the true condition.

Secondary Outcome

1. Setting of major evaluation criteria for true positive rate, specificity, positive predictive value, negative predictive value (true positive rate (ad/bc), sensitivity (a/(a+c)), specificity (d/(b+d)), positive predictive value (a/(a+b)), negative predictive value (D/(c+d)).
2. The true condition of RBD diagnosis, as defined by PSG (diagnosed when chin electromyographic activity exceeds 27% of REM sleep epochs determined in 30-second intervals according to the International Classification of Sleep Disorders), was used to determine the true condition for RBD diagnosis using InSomnoGraph M2 + SleepSCAN. This assessment includes Setting of major evaluation criteria for true positive rate, specificity, positive predictive value, negative predictive value (true positive rate (ad/bc), sensitivity (a/(a+c)), specificity (d/(b+d)), positive predictive value (a/(a+b)), negative predictive value (D/(c+d)).

Key inclusion & exclusion criteria

• Age minimum: >= 40age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

Isolated RBD (iRBD):
1. Patients with normal cognitive function (with a score of 24/30 or higher on the Mini Mental State Examination).
2. Patients without any motor function impairment.
3. Patients clinically exhibiting RBD-like symptoms (talking in their sleep, excessive body movements during sleep).
4. Patients who are strongly suspected of having clinical RBD with a score of 5/13 or higher on the RBDSQ-J questionnaire.
5. Patients whose age at the time of consent is 40 years or older but less than 80 years.
6. Patients who, after receiving sufficient explanation before participating in this study, have given written consent of their own free will with full understanding.

PD-RBD:
1. Patients diagnosed as Clinically Established or Probable PD according to the Movement Disorders Society 2015 PD diagnostic criteria (Mov Disord 30:1591, 2015).
2. Patients clinically exhibiting RBD-like symptoms (talking in their sleep, excessive body movements during sleep).
3. Patients who are strongly suspected of having clinical RBD with a score of 5/13 or higher on the RBDSQ-J questionnaire.
4. Patients whose age at the time of consent is 40 years or older but less than 80 years.
5. Patients who, after receiving sufficient explanation before participating in this study, have given written consent of their own free will with full understanding.

DLB-RBD:
1. Patients diagnosed as Probable DLB according to the DLB diagnostic criteria (Neurology 89:88-100, 2017).
2. Patients clinically exhibiting RBD-like symptoms (talking in their sleep, excessive body movements during sleep).
3. Patients who are strongly suspected of having clinical RBD with a score of 5/13 or higher on the RBDSQ-J questionnaire.
4. Patients whose age at the time of consent is 40 years or older but less than 80 years.
5. Patients who, after receiving sufficient explanation before participating in this study, have given written consent of their own free will with full understanding.

Exclude criteria

1. Patients diagnosed with sleep apnea syndrome and undergoing treatment such as CPAP, for whom wearing the examination equipment is difficult.
2. PD (Parkinson's disease) or DLB (Dementia with Lewy Bodies) patients who experience a significant reduction in the effectiveness of anti-Parkinson's medications during the night and may have difficulty communicating with healthcare providers during those times.
3. Patients who are pregnant or have the potential to become pregnant.
4. Patients with severe involuntary movements (including during sleep), making it difficult to securely wear the testing equipment.
5. Patients with significant skin lesions in the electrode attachment sites (frontal area or posterior earlobe).
6. Other patients whom the principal (coordinating) investigator deems unsuitable as study subjects.

Related Information

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