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NCT04569643

Periodic Limb Movement Syndrome in Patients With Cerebral Small Vessel Disease.

Status unknown Last updated 21 February 2021
What this trial tests

trial testing Actigraphy in Periodic Limb Movement Disorder in 76 participants. Status unknown.

Timeline
1 December 2020
Primary endpoint
30 April 2022
31 August 2022

Quick facts

Lead sponsorI.M. Sechenov First Moscow State Medical University
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment76
Start date1 December 2020
Primary completion30 April 2022
Estimated completion31 August 2022
Sites1 location across Russia

Drugs / interventions tested

Conditions studied

Sponsor

I.M. Sechenov First Moscow State Medical University

Who can join

Adults 60 to 75, any sex, with Periodic Limb Movement Disorder or Cerebral Small Vessel Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients from 60 to 75 years old diagnosed with cerebral small vessel disease with no history of symptomatic stroke, brain tumor, traumatic brain injury, seizures and neurodegenerative or mental disorder will undergo overnight leg actigraphy and cardiorespiratory monitoring. Those of them with apnea/hypopnea index under 5 will be enrolled. Brain MRI and cognitive assessment will be performed at baseline and in 1-year follow-up, sleep quality will be assessed at baseline with self-reported questionnaires. Progression of cerebral small vessel disease markers and cognitive dysfunction will be compared between patients with high periodic limb movement index (the number of periodic limb movement ≥ 15 per hour of sleep) and controls (periodic limb movement index \< 15/h).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Periodic Limb Movements Syndrome in Patients With Cerebral Small Vessel Disease: Protocol for a Prospective Observational Study.
    Spektor E, Fietze I, Poluektov MG. · · 2021 · cited 3× · PMID 34646228 · DOI 10.3389/fneur.2021.700151

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Other trials of Actigraphy

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