An interventional study of PSG and actigraphy recording in Spinal Cord Injuries and Periodic Limb Movement Disorder, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-02-11.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
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.
As secondary objectives, the study aims to:
PLMs appropriate diagnosis appeared mandatory in SCI patients however the accessibility and the delay of availability remain challenging for severe SCI complications in care management.
The study team hypothesize that actigraphy could be able to diagnose PLMs with sufficient reliability (AUC (area under the curve) around 80%) compared to the gold standard (polysomnography) in patients with spinal cord injuries.
Intervention: During a scheduled night recording (polysomnography) 3 actigraphs will be added (1 on the wrist, and 1 on each foot).
Equipment: MotionWatch8®, CamNtech® (marking CE Class 1 device; accord FDA (K132764)).
Methods:
All consecutive eligible patients followed in our tertiary care center (for whom a full night polysomnography is already scheduled) will be informed of the study and proposed to participate.
After signing the informed consent form, all subjects will undergo a full-night examinations: polysomnography (already scheduled in usual care) and actigraphy (addition of 3 devices):
Actigraphy analysis will be provided by:
Actigraphy results will not be communicated to patients or physicians and therefore will not affect patient management.
At the end of the evaluation period, each patient will be offered, if needed, treatment and follow-up in the sleep unit as in usual care.
A study of actigraphy reproducibility will be carried out in a sample of 33 subjects. This study will take place over three consecutive nights during an already scheduled hospitalization (no additional hospitalization night for patients).
Statistical analysis: as described in Outcome Measures.
1,988 studies on the registry are indexed under Spinal Cord Injuries; 516 are open to participants now.
This study's enrollment of 160 is above the median of 24 across 1,594 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,576 studies on the registry; 1,028 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Specific criteria:
No-specific criteria:
All patients will be evaluated and diagnosed according to the records by Gold standard for PLMs diagnosis and also by the actigraphy devices recording.
Procedure: PSG and actigraphy recording
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).
The Receiver Operating Characteristic (ROC) analysis
Area under ROC curve of the actimeter (indices of periodic movement of legs, defined by the ratio between the number of periodic movement of low limbs during sleeping time and estimated sleeping duration in hour), compared with polysomnography to have diagnosis of periodic movement of legs during sleeping (period of sleeping defined by absence of light and movement of up limb of the more mobile with actimeter).
Time frame: Through study completion, an average of 3 years
Predictive values estimation
Sensitivity, specificity, positive and negative predictive values and likelihood ratio of actigraphy compared to polysomnography to diagnose PLMs
Time frame: Through study completion, an average of 3 years
Threshold of PLMs Index
The periodic limb movement index (PLMI), which corresponds to the number of periodic limb movements per hour. The actigraphy will be used to determinate diagnostic threshold of PLMs Index.
Time frame: up to 24 hours
Lower limb nocturnal movements evaluation
Number of lower limb nocturnal movements per recording hour
Time frame: up to 24 hours
PLMs diagnosis based on the actigraphy
PLMs diagnosis (yes / no) based on the actigraphy results
Time frame: Through study completion, an average of 3 years
Kappa coefficient
Kappa coefficient between PLMs diagnoses (yes / no) made by 2 different nurses and between 1 nurse and the automated analysis software
Time frame: Through study completion, an average of 3 years
Actigraphy diagnostic performance
Actigraphy diagnostic performance according to: * the underlying pathology (MS or not) * and lesion completeness (AIS-A vs AIS-B,C, D) AIS: American Spinal Injury Association (ASIA) Impairment Scale; MS: multiple sclerosis.
Time frame: Through study completion, an average of 3 years
Installation time
Installation time between actigraphy and PSG
Time frame: Through study completion, an average of 3 years
Interpretation time
Time of interpretation between actigraphy and PSG
Time frame: Through study completion, an average of 3 years
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Assistance Publique - Hôpitaux de Paris →