Sleep Quality & Spinal Cord Injury

NCT04161612 | Completed

• 1 other identifier: IstPMRTRH-SLP
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Sleep Disorder

Keywords

Sleep quality

Outcome Measures

Primary Outcomes (4)

• Functional Ambulation Classification (FAC)

  FAC is defined in five stages according to the basic motor skills required for functional ambulation. FAC stage 0 is used to indicate non-functional ambulation, and stage 5 is used to indicate independent walking at each speed and on ground

  3 month

• Beck Depression Index (BI)

  The severity of depressive symptoms was assessed using the BDI. This scale consists of 21 categories that evaluate the physical, emotional, cognitive, and motivational symptoms of depression, such as hopelessness, irritability, guilt, feelings of being punished, fatigue, and weight loss

  3 month

• Pittsburgh Sleep Quality Index (PSQI)

  A questionnaire that assesses sleep quality and discomfort over the last 1 month. The total score is between 0-21. A higher total score indicates poor sleep quality. A score of 5 or more indicates poor sleep quality

  3 month

• Epworth sleepiness scale (ESS)

  It is a simple questionnaire that measures daytime sleepiness level. Sleepiness is questioned in cases encountered in daily life. The total score is between 0-24. Daytime sleepiness increases as the score increases

  3 month

Secondary Outcomes (2)

• short-form health survey (SF-36)

  3 month

• Douleur Neuropathique 4 questionnaire

  3 month

Interventions

Demographic characteristics, duration of spinal cord injury, spinal cord injurylevel, etiology, number of intermittent bladder catheterization (IC), number of night time OTHER

Observational clinical study

Also known as: Modified Ashworth Scale, Beck Depression Index,Pittsburgh Sleep Quality Index, Epworth sleepiness scale, Barthel Index ,Douleur Neuropathique 4 questionnaire

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with spinal cord injury hospitalized in our hospital

You may qualify if:

• years of age

You may not qualify if:

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

Sponsors & Collaborators

• Istanbul Physical Medicine Rehabilitation Training and Research Hospital: lead

Study Sites (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, 34192, Turkey (Türkiye)

Location

Related Publications (2)

• 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.

  PMID: 30513274 BACKGROUND

• 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.

  PMID: 23618534 BACKGROUND

MeSH Terms

Conditions

Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders

Interventions

Causality

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias

Intervention Hierarchy (Ancestors)

Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• TUGBA AYDIN, MD

  Istanbul Physical Medicine Rehabilitation Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: November 10, 2019
• First Posted: November 13, 2019
• Study Start: November 10, 2019
• Primary Completion: December 12, 2019
• Study Completion: December 12, 2019
• Last Updated: December 16, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)