Ankylosing Spondylitis (AS)NCT07441239
Patient-Reported Sleep vs Objective Sleep and Physical Activity Measures in Ankylosing Spondylitis: A Pre-Post Study
An observational study of Ankylosing Spondylitis (AS) and Sleep Quality, run by Samsun University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ankylosing Spondylitis (AS), Sleep Quality, Physical Activity
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2015to 31 Oct 2016
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- History of a sleep disorder.
- Use of medications that affect sleep.
- Diagnosis of fibromyalgia.
- Presence of upper airway anatomical obstruction.
About this study
Official title: Evaluation of Sleep Quality and Physical Activity According to Disease Activity Periods in Ankylosing Spondylitis
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
Read the detailed description
Objective: This prospective, single-arm pre-post pilot study characterized patient-reported and objective sleep and physical activity measures in patients with active ankylosing spondylitis (AS) who were planned to start anti-TNF-α therapy as part of routine clinical care despite use of at least two NSAIDs. The primary purpose was to evaluate sleep and physical activity in relation to disease activity periods, rather than to test a prespecified treatment effect.
Design and Participants: Eighteen adults fulfilling the modified New York criteria (mNYC) and classified as active based on BASDAI were enrolled. Assessments were performed at baseline (prior to starting anti-TNF-α therapy) and repeated at 4 months.
Assessments: At both time points, participants completed patient-reported questionnaires and underwent objective measurements. Subjective sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). Objective sleep was assessed by overnight polysomnography (PSG), and physical activity was assessed using a multi-sensor wearable accelerometer (SenseWear Armband, BodyMedia Inc., Pittsburgh, PA, USA). Clinical and psychosocial measures included BASDAI, BASFI, BASMI, ASQoL, and HADS (anxiety and depression). Given the exploratory aim and limited sample size, anti-TNF agent subtypes were not specified in the registry record.
Primary Outcome (PSG): The primary outcome measure was sleep efficiency (%) derived from PSG, assessed at baseline and at 4 months.
Additional PSG parameters included time in bed, sleep period time, total sleep time, stage durations (N1, N2, N3, and REM), arousal index, periodic limb movement index, apnea events, and apnea-hypopnea index (AHI). Wearable-derived parameters included total energy expenditure (kcal/day), total step count (steps/hour), total sedentary time (min/hour), sleep duration (min/hour), and physical activity duration (min/hour).
Statistical Analysis: Distribution of continuous variables was assessed using the Shapiro-Wilk test. Non-normally distributed data were summarized as median (Q1-Q3). Pre-post comparisons were performed using the Wilcoxon signed-rank test. Exploratory Spearman rank correlations examined associations between changes in PSQI subscales and changes in BASDAI, BASFI, BASMI, ASQoL, HADS, and wearable-derived activity parameters. Multiple comparisons were controlled within hypothesis families using the Benjamini-Hochberg false discovery rate (FDR) procedure (FDR-adjusted p<0.05). For sleep efficiency, the Hodges-Lehmann pseudo-median difference and 95% confidence interval were calculated in R; primary analyses were performed in SPSS (v24).
- Medical subject headings
- Spondylitis, Ankylosing, Sleep Initiation and Maintenance Disorders, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AS Patients (Pre-Post | Patients with ankylosing spondylitis receiving routine anti-TNF therapy; assessments were performed before and after treatment." |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep efficiency
Sleep efficiency measured by overnight polysomnography.
Measured: Baseline and 4 months.
Secondary outcomes (2)
Daily Step Count
Daily step count (steps/day) measured with the SenseWear Armband (multi-sensor accelerometer). The device was worn on the non-dominant arm for 3 consecutive days at each assessment; the outcome is the average steps/day across the 3 days. Wear-time compliance required wearing the device for ≥90% of the prescribed period.
Measured: Baseline and 4 months.
Pittsburgh Sleep Quality Index (PSQI) total score
Self-reported sleep quality assessed using the PSQI; total score range 0-21, with higher scores indicating worse sleep quality.
Measured: Baseline and 4 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Aug 2015
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing Spondylitis (AS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07441239
- Sponsor's protocol ID
- 24237859-2015/80
- Status last verified
- Feb 2026
- First submitted
- 18 Feb 2026
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared due to privacy and confidentiality considerations and institutional restrictions
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Sleep Quality and Physical Activity According to Disease Activity Periods in Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT07441239
- Acronym / sponsor ID
- 24237859-2015/80
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Objective: This prospective, single-arm pre-post pilot study characterized patient-reported and objective sleep and physical activity measures in patients with active ankylosing spondylitis (AS) who were planned to start anti-TNF-α therapy as part of routine clinical care despite use of at least two NSAIDs. The primary purpose was to evaluate sleep and physical activity in relation to disease activity periods, rather than to test a prespecified treatment effect.
Design and Participants: Eighteen adults fulfilling the modified New York criteria (mNYC) and classified as active based on BASDAI were enrolled. Assessments were performed at baseline (prior to starting anti-TNF-α therapy) and repeated at 4 months.
Assessments: At both time points, participants completed patient-reported questionnaires and underwent objective measurements. Subjective sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). Objective sleep was assessed by overnight polysomnography (PSG), and physical activity was assessed using a multi-sensor wearable accelerometer (SenseWear Armband, BodyMedia Inc., Pittsburgh, PA, USA). Clinical and psychosocial measures included BASDAI, BASFI, BASMI, ASQoL, and HADS (anxiety and depression). Given the exploratory aim and limited sample size, anti-TNF agent subtypes were not specified in the registry record.
Primary Outcome (PSG): The primary outcome measure was sleep efficiency (%) derived from PSG, assessed at baseline and at 4 months.
Additional PSG parameters included time in bed, sleep period time, total sleep time, stage durations (N1, N2, N3, and REM), arousal index, periodic limb movement index, apnea events, and apnea-hypopnea index (AHI). Wearable-derived parameters included total energy expenditure (kcal/day), total step count (steps/hour), total sedentary time (min/hour), sleep duration (min/hour), and physical activity duration (min/hour).
Statistical Analysis: Distribution of continuous variables was assessed using the Shapiro-Wilk test. Non-normally distributed data were summarized as median (Q1-Q3). Pre-post comparisons were performed using the Wilcoxon signed-rank test. Exploratory Spearman rank correlations examined associations between changes in PSQI subscales and changes in BASDAI, BASFI, BASMI, ASQoL, HADS, and wearable-derived activity parameters. Multiple comparisons were controlled within hypothesis families using the Benjamini-Hochberg false discovery rate (FDR) procedure (FDR-adjusted p<0.05). For sleep efficiency, the Hodges-Lehmann pseudo-median difference and 95% confidence interval were calculated in R; primary analyses were performed in SPSS (v24).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AS Patients (Pre-Post | – | –Patients with ankylosing spondylitis receiving routine anti-TNF therapy; assessments were performed before and after treatment." |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- History of a sleep disorder.
- Use of medications that affect sleep.
- Diagnosis of fibromyalgia.
- Presence of upper airway anatomical obstruction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sleep efficiency
Time frame: Baseline and 4 months.
Sleep efficiency measured by overnight polysomnography.
2 secondary outcomes
Daily Step Count
Time frame: Baseline and 4 months.
Pittsburgh Sleep Quality Index (PSQI) total score
Time frame: Baseline and 4 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared due to privacy and confidentiality considerations and institutional restrictions
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis (AS) and Sleep Quality, run by Samsun University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep efficiency (time frame: Baseline and 4 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.