Clinical trial NCT04161612: Sleep Quality & Spinal Cord Injury
Official title: Sleep Quality in Patients With Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep Disorder
Keywords: Sleep quality
Lead sponsor: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2019-11-13
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with spinal cord injury hospitalized in our hospital

Brief summary: The aim of the study was to evaluate sleep quality in patients with spinal cord injury; to investigate the relationship between sleep and spinal cord level, ambulation status, spasticity, quality of life, daily living activities, depressive status, neuropathic pain

Detailed description: Since survival increases in patients with spinal cord injury, sleep disturbances, which are more frequently observed than the general population and have significant impacts on mortality, impair long-term quality of life.The aim of the study was to evaluate sleep quality in patients with spinal cord injury; to investigate the relationship between sleep and spinal cord level, ambulation status, spasticity, quality of life, daily living activities, depressive status, neuropathic pain Eighty patients with inpatient rehabilitation of spinal cord injury were included in the study.

Demographic characteristics, duration of spinal cord injury, spinal cord injury level, etiology, number of intermittent bladder catheterization (IC), number of night time IC, what time they slept, whether they woke up at night, classification of spinal cord injury were recorded.

Ambulation level with Functional Ambulation Classification (FAC), spasticity with Modified Ashworth Scale (MAS), depressive symptoms with Beck Depression Index (BDI), quality of life with short-form health survey (SF-36), sleep quality The Pittsburgh Sleep Quality Index (PSQI), daytime sleepiness Epworth sleepiness scale (ESS), activity of daily living with Barthel Index (BI), neuropathic pain were evaluated with the Douleur Neuropathique 4 questionnaire (DN4) scale.

Eligibility criteria: Inclusion Criteria:

* 18-65 years of age

Exclusion Criteria:

* Noncooperativity
* Traumatic brain injury or other cerebellar-related neurological disease such as hemiplegia.
* Patients with spinal shock

Primary outcomes:
measure: Functional Ambulation Classification (FAC)
timeFrame: 3 month
measure: Beck Depression Index (BI)
timeFrame: 3 month
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 month
measure: Epworth sleepiness scale (ESS)
timeFrame: 3 month
Secondary outcomes:
measure: short-form health survey (SF-36)
timeFrame: 3 month
measure: Douleur Neuropathique 4 questionnaire
timeFrame: 3 month
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
Study officials:
affiliation: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
name: TUGBA AYDIN, MD
role: STUDY_CHAIR
References:
citation: Hulten VDT, Biering-Sorensen F, Jorgensen NR, Jennum PJ. A review of sleep research in patients with spinal cord injury. J Spinal Cord Med. 2020 Nov;43(6):775-796. doi: 10.1080/10790268.2018.1543925. Epub 2018 Dec 4.
citation: Giannoccaro MP, Moghadam KK, Pizza F, Boriani S, Maraldi NM, Avoni P, Morreale A, Liguori R, Plazzi G. Sleep disorders in patients with spinal cord injury. Sleep Med Rev. 2013 Dec;17(6):399-409. doi: 10.1016/j.smrv.2012.12.005. Epub 2013 Apr 22.