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NCT04946994 · ClinicalTrials.gov registry record · NA

Relationship of Exercise, Sleep, and Inflammation Markers in People Living With HIV

A NA study of HIV and Sleep, sponsored by Christine Horvat Davey.

Completed
Registry status
NA
Development phase
53
Enrollment target
3
Study locations

NCT04946994: Completed NA study of HIV and Sleep, sponsored by Christine Horvat Davey.

NCT04946994 is a NA study of HIV and Sleep that has completed, run by Christine Horvat Davey. The registered enrollment target is 53 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (88% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04946994, a NA study of HIV and Sleep, has completed, sponsored by Christine Horvat Davey.

COMPLETED
Registry status
NA
Development phase
53 participants
Enrollment target
3
Study locations

Study Summary

The purpose of this randomized clinical trial is to characterize the effects of two exercise interventions, high-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME), on sleep and inflammation in older people living with HIV (PWH). This study is a sub-study associated with The High Intensity Exercise Study to Attenuate Limitations and Train Habits in Older Adults with HIV (HEALTH-HIV; NCT04550676). The investigators propose the following aims: Aim 1. Compare the effectiveness of HIIT and CME exercise interventions on sleep in older PWH. Aim 2. Quantify inflammation markers associated with sleep quality (self-report surveys) in older PWH at baseline, between (week 8) and after exercise interventions (HIIT and CME) (week 16). The investigators hypothesize HIIT will lead to greater improvement in sleep quality (duration and quality) compared to CME and older PWH who experience poor sleep quality and the CME intervention will have increased inflammation markers compared to older PWH who experience better sleep quality and the HIIT intervention. The intervention is being delivered by research personnel at the University of Washington associated with the HEALTH-HIV study (NCT04550676). Data for this study will only be collected at the University of Washington site of the HEALTH-HIV study.

Primary Outcome

Change in sleep quality will be assessed through the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a validated, self-report instrument assessing sleep quality. Possible scores range from 0-21, with higher scores indicating poorer sleep quality.

Conditions Studied

Interventions

  • BEHAVIORAL HIIT
  • BEHAVIORAL CME

Study Locations (3)

Colorado

  • University of Colorado - Aurora

Ohio

  • Case Western Reserve University - Cleveland

Washington

  • University if Washington - Seattle

Trial Details

FieldValue
Enrollment Target 53 participants
Start Date 2021-10-01
Est. Completion 2025-05-01
Phase NA
Christine Horvat Davey

1 total trials

What the finished NCT04946994 record still lists

NCT04946994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 53 participants, a relatively small participant target, below the 440-participant average among 303 other HIV trials with a reported enrollment target (88% lower).

The record links to 2 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which HIIT is the first listed.

NCT04946994 reports a single indexed study location in Colorado, Ohio, Washington.

Frequently Asked Questions

What is clinical trial NCT04946994 about?

NCT04946994 is a clinical study titled "Relationship of Exercise, Sleep, and Inflammation Markers in People Living With HIV". The purpose of this randomized clinical trial is to characterize the effects of two exercise interventions, high-intensity interval training (HIIT) and continuous moderate-intensity exercise (CME), on sleep and inflammation in older people living with HIV (PWH). This study is a sub-study associated ...

What is the current status of trial NCT04946994?

This trial is currently completed. It is a NA study. The enrollment target is 53 participants. The study started on 2021-10-01. Estimated completion is 2025-05-01.

What conditions does trial NCT04946994 study?

This clinical trial studies the following conditions: HIV, Sleep.

What interventions are being tested in trial NCT04946994?

The interventions under investigation include: HIIT (BEHAVIORAL), CME (BEHAVIORAL).

Who is sponsoring clinical trial NCT04946994?

This trial is sponsored by Christine Horvat Davey, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04946994 being conducted?

This trial has 3 study locations across Colorado, Ohio, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for HIV

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04946994's enrollment target sits among peer trials

53 214th of 303 higher than 88 of 303 other HIV trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04946994, the US trial registry maintained by the National Library of Medicine. NCT04946994 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.