The Effect of Ulnar Nerve Injury Localization on Sleep Qu... | NCT05177861

Studies
The Effect of Ulnar Nerve Injury Localization on Sleep Quality in Patients With Ulnar Nerve Entrapment Neuropathy

NCT05177861

Sponsor

Yuzuncu Yil University

Status

Completed

Last Update Posted

Apr 28, 2022Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Ulnar Neuropathies

Interventions

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 22, 2022Actual

Primary Completion Date

Mar 20, 2022Actual

Completion Date

Apr 27, 2022Actual

First Submitted Date

Dec 13, 2021

First Submission Date that Met QC Criteria

Jan 3, 2022

First Posted Date

Jan 5, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2022

Last Update Posted Date

Apr 28, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Electromyelography	Other	EMG will be performed only once to determine the ulnar nerve entrapment site in patients.	Diagnostic Test: EMG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EMG	Diagnostic Test	Electromyelography	Electromyelography

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pittsburg Sleep Quality Index	sleep evaluation between 0 and 21 points, higher scores mean a worse outcome.	10 minutes.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Volkan Şah	Yüzüncü Yıl Üniversitesi Tıp Fakültesi	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yuzuncu Yil University		Van		65040	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020424	Ulnar Neuropathies

Ancestor Terms

ID	Term
D020422	Mononeuropathies
D010523	Peripheral Nervous System Diseases
D009468	Neuromuscular Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided