NCT05742776

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Feb 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Feb 2023Jul 2026

First Submitted

Initial submission to the registry

February 15, 2023

Completed
8 days until next milestone

Study Start

First participant enrolled

February 23, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 24, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 9, 2026

Status Verified

March 1, 2026

Enrollment Period

3.1 years

First QC Date

February 15, 2023

Last Update Submit

March 6, 2026

Conditions

Musculoskeletal DiseasesMedian Nerve DiseaseCarpal Tunnel SyndromeUltrasoundSleep Quality

Keywords

Carpal Tunnel SyndromeUltrasonographic evaluationPittsburgh Sleep Quality Index

Outcome Measures

Primary Outcomes (1)

  • Visual Analog Scale (VAS)

    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 Outcomes (5)

  • Boston Carpal Tunnel Syndrome Questionnaire (BCTQ)

    2023.02-2023.05

  • Cross-sectional area of the Median Nerve (CSA)

    2023.02-2023.05

  • Electrophysiological Evaluation

    2023.02-2023.05

  • Hand and Finger Grip Strength Assessment

    2023.02-2023.05

  • Pittsburgh Sleep Quality Index (PSQI)

    2023.02-2023.05

Study Arms (2)

Patient Group

CTS Patients

Other: Assessment of Sleep Quality

Control Group

Healthy Individuals

Other: Assessment of Sleep Quality

Interventions

Assessment of Sleep QualityOTHER

Assessment of Sleep Quality

Patient Group

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Afyonkarahisar Health Sciences University

Afyonkarahisar, Afyonkarahi̇sar, 03200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Padua L, Coraci D, Erra C, Pazzaglia C, Paolasso I, Loreti C, Caliandro P, Hobson-Webb LD. Carpal tunnel syndrome: clinical features, diagnosis, and management. Lancet Neurol. 2016 Nov;15(12):1273-1284. doi: 10.1016/S1474-4422(16)30231-9. Epub 2016 Oct 11.

    PMID: 27751557BACKGROUND

  • Okkesim CE, Serbest S, Tiftikci U, Cirpar M. Prospective evaluation of preoperative and postoperative sleep quality in carpal tunnel release. J Hand Surg Eur Vol. 2019 Mar;44(3):278-282. doi: 10.1177/1753193418808182. Epub 2018 Nov 4.

    PMID: 30394830BACKGROUND

  • Kaymak B, Ozcakar L, Cetin A, Candan Cetin M, Akinci A, Hascelik Z. A comparison of the benefits of sonography and electrophysiologic measurements as predictors of symptom severity and functional status in patients with carpal tunnel syndrome. Arch Phys Med Rehabil. 2008 Apr;89(4):743-8. doi: 10.1016/j.apmr.2007.09.041.

    PMID: 18374007BACKGROUND

MeSH Terms

Conditions

Musculoskeletal DiseasesMedian NeuropathyCarpal Tunnel SyndromeSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersMental Disorders

Study Officials

  • Nuran EYVAZ, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

  • Ali İzzet AKÇİN, MD

    Afyonkarahisar Health Sciences University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali İzzet AKÇİN, MD

CONTACT

+905469347374dr.akcin93@gmail.com

Nuran EYVAZ, MD

CONTACT

+905334262442n_eyvaz@hotmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 15, 2023

First Posted

February 24, 2023

Study Start

February 23, 2023

Primary Completion

April 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

March 9, 2026

Record last verified: 2026-03

Locations

TU(1)