ACTI-MPJ-BM: Periodic Leg Movements' Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?

Sponsor

Assistance Publique - Hôpitaux de Paris (Other)

Overall Status

Recruiting

CT.gov ID

NCT04618978

Collaborator

(none)

160

Enrollment

Location

Arm

33.1

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries Periodic Limb Movement Disorder	Procedure: PSG and actigraphy recording	N/A

Detailed Description

As secondary objectives, the study aims to:

Estimate positive and negative predictive values;
Identify the diagnostic threshold of PLMs index with actigraphy;
Study concordance between actigraphy and polysomnography to detect lower limbs movements;
Evaluate reproducibility between 2 readers and with the new PLMs software;
Study actigraphy reproducibility for this indication over 3 consecutive nights in the same patients (ancillary study);
Compare diagnostic performance according to SCI completeness (AIS-A vs AIS-B, C, D) and underlying pathology (MS, SCI);
Compare installation and interpretation times between actigraphy and PSG.

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):

1 classic actigraph on the wrist to detect light and identify inactivity periods compatible with sleep.
2 new generation Actiwatch actigraphs (MotionWatch) placed on the feet. Polysomnography will incorporate tibialis anterior EMG recording and will be scored by one sleep specialist following American Academy of Sleep Medicine (AASM) scoring criteria.

Actigraphy analysis will be provided by:

An automated software specially developed for this indication (PLMsanalysis software, camNtechR).
A nurse reading unaware of both software's and PSG results.
A second reading will be provided by a second nurse, also unaware of the result of the polysomnography.

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 25, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: PSG and actigraphy device evaluations 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).

Arm

Intervention/Treatment

Other: PSG and actigraphy device evaluations

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).

Outcome Measures

Primary Outcome Measures

The Receiver Operating Characteristic (ROC) analysis [Through study completion, an average of 3 years]
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).

Secondary Outcome Measures

Predictive values estimation [Through study completion, an average of 3 years]
Sensitivity, specificity, positive and negative predictive values and likelihood ratio of actigraphy compared to polysomnography to diagnose PLMs
Threshold of PLMs Index [up to 24 hours]
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.
Lower limb nocturnal movements evaluation [up to 24 hours]
Number of lower limb nocturnal movements per recording hour
PLMs diagnosis based on the actigraphy [Through study completion, an average of 3 years]
PLMs diagnosis (yes / no) based on the actigraphy results
Kappa coefficient [Through study completion, an average of 3 years]
Kappa coefficient between PLMs diagnoses (yes / no) made by 2 different nurses and between 1 nurse and the automated analysis software
Actigraphy diagnostic performance [Through study completion, an average of 3 years]
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.
Installation time [Through study completion, an average of 3 years]
Installation time between actigraphy and PSG
Interpretation time [Through study completion, an average of 3 years]
Time of interpretation between actigraphy and PSG

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient With Spinal Cord Injury from traumatic or medical aetiology (including patient with multiple sclerosis);
Motor testing stability for at least 6 months prior to inclusion;
Patients with complete or incomplete SCI (AIS-A, B, C, D and E);
Neurological level between C4 and L1;
Aged >18 years;
Patients with already scheduled full night polysomnography (PSG);
Affiliated to social security system;
Absence of medical intercurrent event.

Exclusion Criteria:

Specific criteria:

History of lower limbs amputation ;
Cutaneous lesion compromising actigraphy positioning
Presence of spinal cord stimulation equipment, Brindley electrodes, history of spinal cord surgery.

No-specific criteria:

Patient refusal;
Participation in another interventional study involving human participants
Unable to sign informed consent form;
Emergency condition;
Legal protection (i.e. incompetence to provide consent, guardianship, curator or incarceration);
No affiliation to a social security system.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP	Garches		France	92380

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator: Marie Christine BLANDIN, Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP
Study Director: Antoine LEOTARD, MD, Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP