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Tiny study hints Anti-TNF may improve sleep in ankylosing spondylitis

NCT ID NCT07441239

Knowledge-focused Sponsor: Samsun University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed 18 adults with active ankylosing spondylitis who were starting anti-TNF therapy for the first time. Researchers measured their sleep quality using overnight sleep tests and a questionnaire, and tracked their daily step counts with a wearable device. The goal was to see if these measures improved after 4 months of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
anti-TNF therapy
What this could lead to
If successful, this could show that anti-TNF therapy improves sleep and daily activity in people with active ankylosing spondylitis.
What could go wrong
This is a very small pilot study with only 18 participants and no control group, so results may not apply to everyone. It only looks at short-term changes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

18 people

The number who actually took part.

Started

Aug 2015

Finished

Oct 2016

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

ankylosing spondylitis insomnia Motor Activity

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ankylosing spondylitis (AS) Physical activity Sleep quality

More trials for these conditions

Other studies related to the condition(s) this trial covers.