Sleep Quality & Spinal Cord Injury

Completed

• Conditions: Sleep Disorder

• Registration Number: NCT04161612
• Lead Sponsor: Istanbul Physical Medicine Rehabilitation Training and Research 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.

Study Timeline

• Status Verified: 2019-11
• Study Start: 2019-11-10
• Study First Submitted: 2019-11-10
• Study First Submitted QC: 2019-11-10
• Study First Posted: 2019-11-13
• Primary Completion: 2019-12-12
• Study Completion: 2019-12-12
• Last Update Submitted: 2019-12-13
• Last Update Posted: 2019-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epworth sleepiness scale (ESS)	3 month	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
Beck Depression Index (BI)	3 month	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
Pittsburgh Sleep Quality Index (PSQI)	3 month	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
Functional Ambulation Classification (FAC)	3 month	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

Secondary Outcome Measures

Name	Time	Method
short-form health survey (SF-36)	3 month	SF-36 is a widely-used and well-documented health-related quality of life index. The SF-36 survey has eight sub-dimensions, including physical functioning, role limitations due to physical problems, pain, general health perception, mental health, role limitations due to emotional problems, vitality, and social functioning, which are evaluated individually
Douleur Neuropathique 4 questionnaire	3 month	Evaluate neuropathic pain. It consists of 10 questions. The maximum score is 10. Patients with a score of 4 or more are considered to have neuropathic pain

Trial Locations

Locations (1)

Istanbul Physical Medicine Rehabilitation Training and Research Hospital; 🇹🇷 İstanbul, Turkey