Back to resultsThe Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy
Primary Purpose
Ulnar Neuropathies
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
EMG
Sponsored by
About this trial
This is an interventional diagnostic trial for Ulnar Neuropathies
Eligibility Criteria
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
Sites / Locations
- Yuzuncu Yil University
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Electromyelography
Arm Description
EMG will be performed only once to determine the ulnar nerve entrapment site in patients.
Outcomes
Primary Outcome Measures
Pittsburg Sleep Quality Index
sleep evaluation between 0 and 21 points, higher scores mean a worse outcome.
Secondary Outcome Measures
Full Information
NCT ID
NCT05177861
First Posted
December 13, 2021
Last Updated
April 27, 2022
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT05177861
Brief Title
The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy
Official Title
The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
January 22, 2022 (Actual)
Primary Completion Date
March 20, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulnar Neuropathies
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Electromyelography
Arm Type
Other
Arm Description
EMG will be performed only once to determine the ulnar nerve entrapment site in patients.
Intervention Type
Diagnostic Test
Intervention Name(s)
EMG
Intervention Description
Electromyelography
Primary Outcome Measure Information:
Title
Pittsburg Sleep Quality Index
Description
sleep evaluation between 0 and 21 points, higher scores mean a worse outcome.
Time Frame
10 minutes.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Volkan Şah
Organizational Affiliation
Yüzüncü Yıl Üniversitesi Tıp Fakültesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yuzuncu Yil University
City
Van
ZIP/Postal Code
65040
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy
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