ClinicalTrials.gg
CompletedNCT04278170Updated Feb 20, 2020

Sleep Quality in Patients With Rheumatoid Arthritis

An observational study in Rheumatoid Arthritis, sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-20.

Sponsored by Istanbul Physical Medicine Rehabilitation Training and Research Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
100
Ages
18 Years to 80 Years
Sex
All
01

Study summary

This study was designed to investigate the factors affecting sleep quality of Rheumatoid arthritis patients in Turkish population.

Read the detailed description

Demographic data, duration of disease, routine biochemical tests and currently used medications were recorded. Disease activity was assessed with Disease Activity Score 28 (DAS 28). Visual Analog Scale (VAS) was used to evaluate pain levels. Health Assessment Questionnaire (HAQ) was used to assess activities of daily living. Beck depression inventory (BDI) was used to investigate the signs of depression in patients. Sleep quality was considered to be poor in patients with a Pittsburgh Sleep Quality Index (PSQI) global score of 5 and greater.

02

Conditions studied

  • Rheumatoid Arthritis

Keywords

  • sleeping disorders
  • sleep quality
03

In context

Arthritis, Rheumatoid

2,962 studies on the registry are indexed under Arthritis, Rheumatoid; 396 are open to participants now.

This study's enrollment of 100 is below the median of 176 across 854 observational studies indexed under Arthritis, Rheumatoid.

Browse Arthritis, Rheumatoid studies →

Lead sponsor

Istanbul Physical Medicine Rehabilitation Training and Research Hospital is the lead sponsor of 123 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Sampling method
Probability sample

Study population

Rheumatoid arthritis patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients with RA who met the 2010 American College of Rheumatology (ACR) RA classification criteria were included

Exclusion criteria

Exclusion Criteria:

  • Patients who had difficulties understanding and responding to questions were excluded from the study.
05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
100 participants (actual)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • Case group

    Rheumatoid arthritis patients who met the American College of Rheumatology (ACR) 2010 RA classification

    Other: no attempt was made to patients

Interventions

  • Otherno attempt was made to patients

    no attempt was made to patients

06

What researchers measure

Primary outcomes

  1. The factor affecting sleep quality of Rheumatoid arthritis patients

    Demographic data

    Time frame: 1 day

  2. duration of disease

    factor affecting sleep quality of Rheumatoid arthritis patients

    Time frame: 1 day

  3. Sleep quality of Rheumatoid arthritis patients

    Pittsburg Sleep Quality Index (PSQI) was used to evaluate the sleep quality of the patients. PSQI is a questionnaire which assesses sleep quality by questioning the patient on 7 main sections; i.e., subjective sleep quality, sleep latency, sleep duration, habitual sleep activity, sleep disorders, use of sleep medication and daytime dysfunctions. Questions are scored from 0 to 3, high scores reflecting poor sleep quality. Seven main components are first evaluated individually and then the scores are added. A total score of 5 and above indicates poor sleep quality

    Time frame: 1 day

  4. Disease activity of Rheumatoid arthritis patients

    Disease activity was assessed with Disease Activity Score 28 (DAS 28).

    Time frame: 1 day

  5. The pain evaluating of Rheumatoid arthritis patients

    Visual Analog Scale (VAS) was used to evaluate pain levels.

    Time frame: 1 day

  6. General health of Rheumatoid arthritis patients

    Health Assessment Questionnaire (HAQ) was used to assess activities of daily living.

    Time frame: 1 day

  7. Depression of Rheumatoid arthritis patients

    Beck depression inventory (BDI) was used to investigate the signs of depression in patients.

    Time frame: 1 day

07

Study locations

1 site
  • Istanbul Physical Medicine and Rehabilitation Training and Research Hospital
    Istanbul, 34186, Turkey (Türkiye)
08

References and documents

Publications

  • Szady P, Baczyk G, Kozlowska K. Fatigue and sleep quality in rheumatoid arthritis patients during hospital admission. Reumatologia. 2017;55(2):65-72. doi: 10.5114/reum.2017.67600. Epub 2017 Apr 28. PubMed 28539677 ↗
  • Purabdollah M, Lakdizaji S, Rahmani A, Hajalilu M, Ansarin K. Relationship between Sleep Disorders, Pain and Quality of Life in Patients with Rheumatoid Arthritis. J Caring Sci. 2015 Sep 1;4(3):233-41. doi: 10.15171/jcs.2015.024. eCollection 2015. PubMed 26464840 ↗
  • Goes ACJ, Reis LAB, Silva MBG, Kahlow BS, Skare TL. Rheumatoid arthritis and sleep quality. Rev Bras Reumatol Engl Ed. 2017 Jul-Aug;57(4):294-298. doi: 10.1016/j.rbre.2016.07.011. Epub 2016 Aug 12. English, Portuguese. PubMed 28743355 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04278170
Responsible party
Sponsor
First posted
Feb 20, 2020
Start date
May 15, 2014
Primary completion
Jun 15, 2015
Completion
Oct 15, 2018
Last update
Feb 20, 2020

Study contacts

Aysenur Bardak, MD
study director · Istanbul Physical Therapy and Rehabilitation Research and Training Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion