Sleep Quality & Spinal Cord Injury (SLP)

December 13, 2019 updated by: Tuğba Aydın, Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Sleep Quality in Patients With Spinal Cord Injury

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • İstanbul, Turkey, 34192
        • Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with spinal cord injury hospitalized in our hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional Ambulation Classification (FAC)
Time Frame: 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
3 month
Beck Depression Index (BI)
Time Frame: 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
3 month
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 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
3 month
Epworth sleepiness scale (ESS)
Time Frame: 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
3 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
short-form health survey (SF-36)
Time Frame: 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
3 month
Douleur Neuropathique 4 questionnaire
Time Frame: 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
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 10, 2019

Primary Completion (ACTUAL)

December 12, 2019

Study Completion (ACTUAL)

December 12, 2019

Study Registration Dates

First Submitted

November 10, 2019

First Submitted That Met QC Criteria

November 10, 2019

First Posted (ACTUAL)

November 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

December 16, 2019

Last Update Submitted That Met QC Criteria

December 13, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IstPMRTRH-SLP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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