CompletedNot Applicable

Patient-Reported Sleep vs Objective Sleep and Physical Activity Measures in Ankylosing Spondylitis: A Pre-Post Study

18 participantsStarted 2015-08-01

Plain-language summary

Eighteen patients with active ankylosing spondylitis were evaluated at initiation of anti-TNF-α therapy and again after 4 months. Subjective sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI). Objective sleep parameters were measured by overnight polysomnography, and physical activity was assessed using a multi-sensor wearable accelerometer. Clinical outcomes included BASDAI/BASFI, ASQoL, and HADS. This was a prospective, single-arm pre-post pilot study

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adults with active ankylosing spondylitis (AS) meeting the modified New York criteria (mNYC) * Active disease defined as BASDAI ≥ 4. * Inadequate response despite use of at least two NSAIDs (per routine clinical decision to initiate anti-TNF-α). * Biologic-naïve (no prior anti-TNF/biologic therapy). Exclusion Criteria * History of a sleep disorder. * Use of medications that affect sleep. * Diagnosis of fibromyalgia. * Presence of upper airway anatomical obstruction.

What they're measuring

Sleep efficiency

Timeframe: Baseline and 4 months.

Trial details

NCT IDNCT07441239

SponsorSamsun University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-10-31

View on ClinicalTrials.gov More Ankylosing Spondylitis (AS) trials