Periodic Leg Movement's Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- The Receiver Operating Characteristic (ROC) analysis
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
The Receiver Operating Characteristic (ROC) analysis
时间窗: 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).
次要结局
- Predictive values estimation(Through study completion, an average of 3 years)
- Interpretation time(Through study completion, an average of 3 years)
- Threshold of PLMs Index(up to 24 hours)
- Lower limb nocturnal movements evaluation(up to 24 hours)
- PLMs diagnosis based on the actigraphy(Through study completion, an average of 3 years)
- Kappa coefficient(Through study completion, an average of 3 years)
- Actigraphy diagnostic performance(Through study completion, an average of 3 years)
- Installation time(Through study completion, an average of 3 years)