The Relationship Between Ultrasonographic Findings and Sleep Quality in Carpal Tunnel Syndrome

March 6, 2026 updated by: Nuran Eyvaz, Afyonkarahisar Health Sciences University

The Relationship Between Ultrasonographic Findings and Sleep Quality in Patients With Carpal Tunnel Syndrome

The aim of our study is to determine the relationship between disease severity and sleep quality in CTS patients and to compare the findings with healthy controls.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Carpal tunnel syndrome is the most common form of entrapment neuropathies. Anatomically, the roof of the carpal tunnel consists of carpal bones, it is located under the transverse carpal ligament, and there are 9 tendon packs of the forearm flexors and the median nerve. Clinically, sensory (paresthesia and hypoesthesia), motor deficits and pain occur in the distribution of the median nerve secondary to mechanical compression and local ischemia.

With the increase in the severity of the disease, entrapment neuropathy, whose symptoms are more pronounced at night, negatively affects the daily life of the person. Waking up at night due to paresthesia is one of the diagnostic criteria for carpal tunnel syndrome. However, the mechanism linking CTS with insomnia is unclear.

The aim of our study is to determine the relationship between disease severity and sleep quality in CTS patients.

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Turkey (Türkiye)
    • Afyonkarahi̇sar
      • Afyonkarahisar, Afyonkarahi̇sar, Turkey (Türkiye), 03200
        • Recruiting
        • Afyonkarahisar Health Sciences University
        • Contact:
        • Contact:

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

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

90 patients with CTS and 30 patients with gonarthrosis as control group, aged between 20-80 years who applied to our clinic will be included in the study.

Description

Inclusion Criteria:

  • Patients diagnosed with CTS according to the criteria of the American Academy of Neurology

Exclusion Criteria:

  • Patients with radiculopathy, brachial plexopathy, thoracic outlet syndrome and traumatic nerve injury that may affect the median nerve
  • History of Carpal tunnel surgery
  • Pregnancy
  • Malignancy
  • Thyroid diseases
  • Amyloidosis
  • Systemic lupus erythematosus, Rheumatoid arthritis, Systemic sclerosis, Gout, Dermatomyositis, Polymyositis
  • Obstructive sleep apnea

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control Group
Healthy Individuals
Other: Assessment of Sleep Quality
Assessment of Sleep Quality
Patient Group
CTS Patients
Other: Assessment of Sleep Quality
Assessment of Sleep Quality

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale (VAS)
Time Frame: 2023.02-2023.05
Pain intensity was measured with visual analogue scale for pain (0-10 mm; 0 means no pain, 10 means severe pain) which is used to measure musculoskeletal pain with very good reliability and validity.
2023.02-2023.05

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)
Time Frame: 2023.02-2023.05
The Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) is a frequently used questionnaire for CTS that includes 2 components. It evaluates for grading under two sub-headings: symptom severity scale (11 questions) and functional status scale (8 questions). Scores range from 0 to 5 for each question; 0 represents no difficulty during the activity, 5 represents extremely severe dysfunction.
2023.02-2023.05
Cross-sectional area of the Median Nerve (CSA)
Time Frame: 2023.02-2023.05

The cross-sectional area (CSA) of the median nerve will be used for analysis by the mean value of 3 measurements made with an electronic caliper at scaphoid-pisiform level. Ultrasonographic evaluations were planned to be performed with the 10-18-MHz linear probe of the MyLab 70 (Esaote, Genova, Italy) device by a physician experienced in US.

CSA values increase as clinical findings worsen.
2023.02-2023.05
Electrophysiological Evaluation
Time Frame: 2023.02-2023.05
The patients will be evaluated as mild-moderate-severe CTS according to the criteria of the American Academy of Neurology.
2023.02-2023.05
Hand and Finger Grip Strength Assessment
Time Frame: 2023.02-2023.05
The hand grip strength of the participants will be measured with the "Jamar Hand Dynamometer". Measurements will be made with the shoulder in adduction and neutral rotation adjacent to the trunk, elbow 90 degrees flexed, wrist 0-30 degrees dorsiflexion and 0-15 degrees ulnar deviation with thumb up. Finger grip strength will be evaluated with the "Jamar Digital Pinchmeter". Patients will be placed in the sitting position with the wrist in 90° flexion and the forearm in the neutral position. Measurements will be made bilaterally in three different positions as lateral, palmar and fingertip grips. Patients will be asked to squeeze with maximum force and each measurement will be made three times, and their averages will be recorded in kg. The dynamometer has a dual scale readout which displays isometric grip force from 0-90 kg. Higher scores means better grip strength.
2023.02-2023.05
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: 2023.02-2023.05
Pittsburgh Sleep Quality Index (PSQI) is a questionnaire that assesses sleep patterns and sleep quality in adults. The measure consists subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping pills, and daytime dysfunction in the past month. The global score of PUKI and each sub-parameter will be calculated and recorded separately. According to the PSQI, "good sleepers" are defined as a PSQI score = <5 and "bad sleepers" as PSQI > 5.
2023.02-2023.05

Collaborators and Investigators

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

Sponsor

Afyonkarahisar Health Sciences University

Investigators

  • Principal Investigator: Nuran EYVAZ, MD, Afyonkarahisar Health Sciences University
  • Principal Investigator: Ali İzzet AKÇİN, MD, Afyonkarahisar Health Sciences University

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)

February 23, 2023

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

February 15, 2023

First Submitted That Met QC Criteria

February 15, 2023

First Posted (Actual)

February 24, 2023

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 6, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTSPUKI23

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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