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Sleep Quality & Spinal Cord Injury

NCT ID: NCT04161612

Last Updated: 2019-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-10

Study Completion Date

2019-12-12

Brief Summary

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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

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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.

Conditions

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Sleep Disorder

Keywords

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Sleep quality

Study Design

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Observational Model Type

OTHER

Study Time Perspective

CROSS_SECTIONAL

Interventions

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

Observational clinical study

Intervention Type OTHER

Other Intervention Names

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

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Tuğba Aydın

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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TUGBA AYDIN, MD

Role: STUDY_CHAIR

Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Locations

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Istanbul Physical Medicine Rehabilitation Training and Research Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30513274 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23618534 (View on PubMed)

Other Identifiers

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IstPMRTRH-SLP

Identifier Type: -

Identifier Source: org_study_id