- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05177861
The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy
April 27, 2022 updated by: Volkan Şah, Yuzuncu Yıl University
Regardless of the cause of ulnar nerve entrapment neuropathy, we are planning to investigate the relationship between sleep quality disorder that may develop due to ulnar neuropathy and the level of entrapment in electromyelography.
Study Overview
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
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
-
-
-
Van, Turkey, 65040
- Yuzuncu Yil University
-
-
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
Description
Inclusion Criteria:
- having ulnar nerve entrapment neuropathy with clinical examination and EMG (electroneuromyography)
- to be between the ages of 18-65
- be give informed consent
Exclusion Criteria:
- malignancy
- surgical history in the ipsilateral upper extremity
- sleep apnea
- narcolepsy
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
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Electromyelography
EMG will be performed only once to determine the ulnar nerve entrapment site in patients.
|
Electromyelography
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pittsburg Sleep Quality Index
Time Frame: 10 minutes.
|
sleep evaluation between 0 and 21 points, higher scores mean a worse outcome.
|
10 minutes.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 22, 2022
Primary Completion (Actual)
March 20, 2022
Study Completion (Actual)
April 27, 2022
Study Registration Dates
First Submitted
December 13, 2021
First Submitted That Met QC Criteria
January 3, 2022
First Posted (Actual)
January 5, 2022
Study Record Updates
Last Update Posted (Actual)
April 28, 2022
Last Update Submitted That Met QC Criteria
April 27, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Nervous System Diseases
- Wounds and Injuries
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Neuromuscular Diseases
- Neurodegenerative Diseases
- Mononeuropathies
- Peripheral Nervous System Diseases
- Cumulative Trauma Disorders
- Sprains and Strains
- Heredodegenerative Disorders, Nervous System
- Nervous System Malformations
- Polyneuropathies
- Nerve Compression Syndromes
- Charcot-Marie-Tooth Disease
- Hereditary Sensory and Motor Neuropathy
- Ulnar Neuropathies
- Ulnar Nerve Compression Syndromes
Other Study ID Numbers
- 100th year University Van
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.