NCT04618978Befejeződött
Periodic Leg Movements' Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?
Periodic Leg Movement's Diagnosis in Spinal Cord Injury: Actigraphy as an Alternative for Polysomnography?
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. febr. 11.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 160 (tényleges)
- Első benyújtás
- 2020. okt. 23.
- Kezdés
- 2021. febr. 25.
- Elsődleges befejezés
- 2024. júl. 4.
- Fő szponzor
- Assistance Publique - Hôpitaux de Paris
- Betegségek
- Sclerosis multiplex (SM)
- NCT-szám
- NCT04618978
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Bevont résztvevők: 160
- 2021. febr. 25. és az elsődleges befejezés (2024. júl. 4.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- History of lower limbs amputation ;
- Presence of spinal cord stimulation equipment, Brindley electrodes, history of spinal cord surgery.
- No-specific criteria:
- Emergency condition;
Egyéb
- Specific criteria:
- Cutaneous lesion compromising actigraphy positioning
- Patient refusal;
- Participation in another interventional study involving human participants
- Unable to sign informed consent form;
- Legal protection (i.e. incompetence to provide consent, guardianship, curator or incarceration);
- No affiliation to a social security system.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| Physiologie, explorations fonctionnelles - Unité des pathologies du sommeil, Hôpital Raymond Poincaré, APHP | Garches | Franciaország | Ismeretlen állapot |
Ez az oldal tájékoztatás, nem orvosi tanács. Bármely vizsgálatról az orvosoddal beszélj.