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Sleepless nights may worsen pain and inflammation in HIV patients

NCT ID NCT04298658

Knowledge-focused Sponsor: University of Alabama at Birmingham 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This completed study looked at 171 people with HIV to see if insomnia makes pain worse and increases inflammation. Participants wore sleep trackers, kept sleep diaries, and underwent pain tests. The goal was to understand if poor sleep drives pain and inflammation, which could make insomnia a target for future treatments.

What this could mean

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

What this could lead to
If successful, this research could confirm that treating insomnia helps reduce pain and inflammation in people living with HIV.
What could go wrong
This is an observational study, not a treatment trial. It may only show a link, not prove that fixing insomnia directly improves pain or inflammation.

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

171 people

The number who actually took part.

Started

Jan 2020

Finished

Jul 2025

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

120 individuals with HIV (60 with insomnia \& 60 without insomnia) as well as a group of 120 individuals without HIV as Controls (60 with insomnia \& 60 without insomnia), for a total sample size of 240 individuals.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: HIV with Insomnia * Confirmed HIV diagnosis * currently a patient in the University of Alabama (UAB) 1917 HIV Clinic. * must be currently receiving stable antiretroviral therapy (ART). * Meets the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty. HIV Without Insomnia * Confirmed HIV diagnosis * currently a patient in the University of Alabama (UAB) 1917 HIV Clinic. * must be currently receiving stable antiretroviral therapy (ART). * Does not meet the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnostic criteria for insomnia including sleep difficulty. Non HIV with Insomnia * Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic. * Meets DSM-5 diagnostic criteria for insomnia including sleep difficulty. Non HIV Without Insomnia * Confirmed Non HIV diagnosis and currently not a patient in the UAB 1917 HIV Clinic. * Does not meets DSM-5 diagnostic criteria for insomnia including sleep difficulty. Exclusion Criteria: * concurrent medical conditions that could confound * interpretation of sleep * pain * inflammatory issues or coexisting diseases * Systemic rheumatic disease/condition * uncontrolled hypertension (i.e., BP \> 150/95) * circulatory disorders (e.g., Reynaud's disease) * history of heart disease or cardiac events * history of cancer * asthma AND use of an inhaler * history of seizures * history of stroke or other neurological disorder * pregnancy * core body temperature \> 100 degrees Fahrenheit as this could indicate acute infection with fever; (k) * unwilling to provide blood for this study * non-English speaking * recent injury or surgical procedure within past 6 months.

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Conditions

The condition(s) this trial relates to.

HIV infectious disease insomnia

As listed by the trial registrant

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

HIV Insomnia

Contacts and locations

Locations

  • UAB

    Birmingham, Alabama, 35294, United States

More trials for these conditions

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