Skip to content

Clinical research about neuroprotection of idebenone on rapid eye movement sleep behaviour disorder

Clinical research about neuroprotection of idebenone on rapid eye movement sleep behaviour disorder

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017395
Enrollment
Unknown
Registered
2018-07-28
Start date
2018-09-01
Completion date
Unknown
Last updated
2018-07-31

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

Conditions

rapid eye movement sleep behaviour disorder

Interventions

treatment group with idebenone:idebenone 30mg po tid
control group with placebo :placebo 1pill po tid

Sponsors

Shaanxi Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 80 Years

Inclusion criteria

Inclusion criteria: Polysomnography should be performed in RBD patients with associated clinical symptoms.The diagnostic criteria for RBD are in accordance with the the second edition of the International Classification of Sleep Disorders (ICSD-2) 6, which emphasizes the high sensitivity and specificity of polysomnography: 1. REM sleep without flaccid: electromyography shows that the amplitude of the submental electromyography is continuous or intermittent, or excessive occurrence of mental or limb myoelectric twitching during the excessive occurrence of mental or limb myoelectric convulsions; 2. Meet at least one of the following items: (1) with history of sleep related injury, potential injury or destructive action; (2) PSG monitoring video The abnormal behavior of the REM sleep period; (3) REM sleep period electroencephalogram (EEG) without epileptic activity, or can clearly distinguish between RBD and any other epilepsy in the same period of REM sleep; (4) its sleep disease can not be explained by other sleep diseases, internal medical or mental illness, and drug use.

Exclusion criteria

Exclusion criteria: (1) known severe vascular encephalopathy or normal pressure hydrocephalus on magnetic resonance imaging(MRI); (2) current or past treatment with antipsychotic drugs; (3) sleep disorder was induced by any other severe disease, such as severe anemia, hyperthyroidism, tumor and so on.

Design outcomes

Primary

MeasureTime frame
Index of rapid eye movement sleep;Index of rapid eye movement sleep;

Countries

China

Contacts

Public ContactHou Chen

Shaanxi Provincial People's Hospital

smilegirl29@163.com+86 18092661881

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026