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

NCT07441239 | Completed

• 1 other identifier: 24237859-2015/80
• Study Type: observational
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Ankylosing Spondylitis (AS); Sleep Quality; Physical Activity

Outcome Measures

Primary Outcomes (1)

• Sleep efficiency

  Sleep efficiency measured by overnight polysomnography.

  Baseline and 4 months.

Secondary Outcomes (2)

• Daily Step Count

  Baseline and 4 months.

• Pittsburgh Sleep Quality Index (PSQI) total score

  Baseline and 4 months.

Study Arms (1)

AS Patients (Pre-Post

Patients with ankylosing spondylitis receiving routine anti-TNF therapy; assessments were performed before and after treatment."

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A total of 18 patients with active ankylosing spondylitis who met the modified New York criteria (mNYC) were enrolled in this prospective study. Disease activity was assessed using the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). Patients were eligible if they had persistent active disease despite treatment with at least two NSAIDs and if anti-TNF-α therapy was planned as part of routine clinical care. Patients who agreed to participate in the study and provided informed consent were included.

You may qualify if:

• 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).

You may not qualify if:

• History of a sleep disorder.
• Use of medications that affect sleep.
• Diagnosis of fibromyalgia.
• Presence of upper airway anatomical obstruction.

Sponsors & Collaborators

• Samsun University: lead

MeSH Terms

Conditions

Spondylitis, Ankylosing; Sleep Initiation and Maintenance Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2026
• First Posted: February 27, 2026
• Study Start: August 1, 2015
• Primary Completion: October 31, 2016
• Study Completion: October 31, 2016
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share