CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 160 enrolled
Drug / intervention
PSG and actigraphy recordingprocedure
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04618978
NCT04618978N/ACompleted

Periodic Leg Movement's Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?

Assistance Publique - Hôpitaux de Paris·interventional·Posted Nov 6, 2020·Updated Feb 11, 2025

In Brief

A clinical study evaluating PSG and actigraphy recording for Spinal Cord Injuries and Periodic Limb Movement Disorder. Completed, enrolled 160 participants across 1 site.

Detailed Summary

Periodic Limb Movements during Sleep (PLMs) are episodes of repetitive, stereotypical, hallux or foot movements. They could induce sleep disturbance, fatigue, daytime sleepiness and impaired quality of life but also increased cardiovascular risk by rising heart rate and blood pressure at night. Gold standard for PLMs diagnosis is based on electromyographic recording of tibialis anterior muscle during full night polysomnography (PSG). PLMs prevalence is higher in patients with spinal cord injury (SCI) possibly due to a loss of encephalic inhibition on a spinal motion generator. In these patients, PLMs can also be wrongly considered as spasms sometimes leading to the unjustified implantation of an intrathecal Lioresal pump. In the general population, drug treatments for PLMs, particularly dopamine agonists, limit the impact of these abnormal movements on sleep fragmentation, daytime alertness and quality of life. Underdiagnosed PLMs in SCI patients can lead to exacerbate cognitive, mood and painful disorders due to the close interaction between sleep disorders and neurocognitive, psychological and painful manifestations. PLMs appropriate diagnosis appeared mandatory in those patients but accessibility and delayed availability remain challenging. In addition, sleep laboratories are often unable to accommodate with SCI patients. In this context, actigraphy, an easy-to-use, cheaper and easily renewable diagnostic tool would be interesting. In the general population, sensitivity to diagnose PLMs was between 0.79 and 1 and specificity between 0.6 and 0.83. Due to lower limbs impairment, increased specificity is expected SCI patients (decrease voluntary activity). The new generation of actigraph (MotionWatchR) could have better characteristics thanks to the development of a specific software which integrate both lower limbs in the same analysis. As primary objective, this prospective monocentric study aims to evaluate the performances of lower limbs actigraphy for PLMs diagnosis versus gold standard.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedNov 6, 2020
Enrollment StartFeb 25, 2021
Primary CompletionJul 4, 2024
Study CompletionJan 17, 2025
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 5.7 years ago

Interventions

PSG and actigraphy recordingprocedure

Gold standard: electromyographic recording of tibialis anterior muscle during full night polysomnography (PSG). The new generation actigraphs devices Actiwatch will be combined to PSG as a screening tool: MotionWatch will be placed on the dorsum of feet to record).