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NCT04458194 · ClinicalTrials.gov registry record · NA
Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors
A NA study of Insomnia, sponsored by University of Rochester.
- Active
- Registry status
- NA
- Development phase
- 42
- Enrollment target
- 2
- Study locations
NCT04458194: Active NA study of Insomnia, sponsored by University of Rochester.
NCT04458194 is a NA study of Insomnia that is active but no longer recruiting, run by University of Rochester. The registered enrollment target is 42 participants, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (75% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04458194, a NA study of Insomnia, is active but no longer recruiting, sponsored by University of Rochester.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 42 participants
- Enrollment target
- 2
- Study locations
Study Summary
This feasibility phase II randomized controlled trial examines the preliminary efficacy of our standardized four-week YOCAS©® (Yoga for Cancer Survivors) intervention that is delivered virtually on insomnia and sleep quality in cancer survivors. Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty staying asleep, or waking up earlier than desired. The vast majority of patients with cancer experience some form of sleep impairment post-treatment. Yoga is safe, feasible, and effective for improving insomnia and sleep quality in cancer survivors. However, most of the yoga intervention was delivered in person. With the challenges and the social distancing regulation regarding the COVID-19 pandemic, adapting to virtual behavioral intervention is critically important and needed. Whether the yoga intervention delivered virtually to survivors provides a similar benefit of improving insomnia and sleep quality is unknown.
Primary Outcome
The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change among cancer survivors in YOCAS vs. Standard Care
Conditions Studied
Interventions
- OTHER Standard Care
- BEHAVIORAL YOCAS©® yoga
Study Locations (2)
New York
- Bassett Research Institute - Cooperstown
- University of Rochester Medical Center - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2022-01-12 |
| Est. Completion | 2026-11-30 |
| Phase | NA |
What the registry record for NCT04458194 still lists
NCT04458194 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 170-participant average among 151 other Insomnia trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Insomnia appearing as the primary indexed condition, and to 2 interventions - of which Standard Care is the first listed.
NCT04458194 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT04458194 about?
NCT04458194 is a clinical study titled "Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors". This feasibility phase II randomized controlled trial examines the preliminary efficacy of our standardized four-week YOCAS©® (Yoga for Cancer Survivors) intervention that is delivered virtually on insomnia and sleep quality in cancer survivors. Insomnia can be described as excessive daytime nappin...
What is the current status of trial NCT04458194?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 42 participants. The study started on 2022-01-12. Estimated completion is 2026-11-30.
What conditions does trial NCT04458194 study?
This clinical trial studies the following conditions: Insomnia.
What interventions are being tested in trial NCT04458194?
The interventions under investigation include: Standard Care (OTHER), YOCAS©® yoga (BEHAVIORAL).
Who is sponsoring clinical trial NCT04458194?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04458194 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Insomnia
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 NCT04458194's enrollment target sits among peer trials
42 113th of 151 higher than 39 of 151 other Insomnia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Insomnia 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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