Sleep Quality & Spinal Cord Injury

Sleep Disorder Clinical Trial

— SLP  

Official title:

Sleep Quality in Patients With Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04161612
• Other study ID #: IstPMRTRH-SLP
• Status: Completed
• Start date: November 10, 2019
• Est. completion date: December 12, 2019

Study information

• Verified date: November 2019
• Source: Istanbul Physical Medicine Rehabilitation Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 12, 2019
• Est. primary completion date: December 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Sleep Disorder
• Sleep Wake Disorders
• Spinal Cord Injuries

Intervention

Other:
• Demographic characteristics, duration of spinal cord injury, spinal cord injurylevel, etiology, number of intermittent bladder catheterization (IC), number of night time
Observational clinical study

Locations

Country	Name	City	State
Turkey	Istanbul Physical Medicine Rehabilitation Training and Research Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. Review. — View Citation

Hultén VDT, Biering-Sørensen F, Jørgensen NR, Jennum PJ. A review of sleep research in patients with spinal cord injury. J Spinal Cord Med. 2018 Dec 4:1-22. doi: 10.1080/10790268.2018.1543925. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	short-form health survey (SF-36)	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	3 month
Secondary	Douleur Neuropathique 4 questionnaire	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	3 month