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NCT04566822 · ClinicalTrials.gov registry record · NA
Calm Sleep Coaching
A NA study of Sleep Disturbance, sponsored by Arizona State University.
- Completed
- Registry status
- NA
- Development phase
- 388
- Enrollment target
- 1
- Study location
NCT04566822: Completed NA study of Sleep Disturbance, sponsored by Arizona State University.
NCT04566822 is a NA study of Sleep Disturbance that has completed, run by Arizona State University. The registered enrollment target is 388 participants, above the 171-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (127% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04566822, a NA study of Sleep Disturbance, has completed, sponsored by Arizona State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 388 participants
- Enrollment target
- 1
- Study location
Study Summary
The Centers for Disease Control and Prevention has identified insufficient sleep as a public health epidemic, with more than 70 million US adults experiencing insomnia each year. However, access to current evidence-based interventions for sleep disturbance (e.g., Cognitive Behavior Therapy for Insomnia \[CBT-I\]) is limited due to the need for specialized providers as well as monetary and logistical barriers that prevent many individuals from attending in-person treatment sessions (e.g., scheduling, transportation, childcare). Novel modes of delivery are needed to extend the benefits of these treatments to a wider range of individuals in need. The purpose of this study is to evaluate Calm Sleep Coaching in adults with sleep disturbance (score of greater than or equal to 8 on the Insomnia Severity Index) by 1) determining the feasibility (i.e., acceptability, demand) of Calm Sleep Coaching and 2) determining the preliminary effects of Calm Sleep Coaching on primary (sleep quality) and secondary outcomes (i.e., symptoms of insomnia, mental health, well-being, resilience, and productivity). Investigators also aim to explore coaches' experiences with implementation of Calm Sleep Coaching using an investigator developed survey and assess the participants stage of change (transtheoretical model) throughout the program. Investigators hypothesize that 1) Calm Sleep Coaching will be feasible among individuals with sleep disturbance and 2) participating in the Calm Sleep Coaching program is associated with improvements in primary and secondary outcomes compared to the control group (with greater improvements observed among those participating in higher touch coaching interventions). Investigators aim to recruit N=200 participants. Participants will be randomized into one of four groups: 1) High-touch intervention (N=50; real-time video and chat messaging, coach response via live videos), 2) medium-touch intervention (N=50; real-time video and pre-recorded video and chat mes
Primary Outcome
Sleep Disturbance will be measured with the Insomnia Severity Index. Scores range from 0-28 with higher score indicates more severe insomnia.
Conditions Studied
Interventions
- BEHAVIORAL High Touch intervention
- BEHAVIORAL Medium Touch intervention
- BEHAVIORAL Low Touch intervention
- BEHAVIORAL Sleep Education Control
Study Locations (1)
Arizona
- Arizona State University - Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 388 participants |
| Start Date | 2020-09-21 |
| Est. Completion | 2020-12-22 |
| Phase | NA |
What the finished NCT04566822 record still lists
NCT04566822 is an interventional study that assigns participants to a tested intervention. The registered 388 participants enrollment target is mid-sized for trials with a published cap, above the 171-participant average among 56 other Sleep Disturbance trials with a reported enrollment target (127% higher).
The record links to 1 condition, with Sleep Disturbance appearing as the primary indexed condition, and to 4 interventions - of which High Touch intervention is the first listed.
NCT04566822 reports a single indexed study location in Arizona.
Frequently Asked Questions
What is clinical trial NCT04566822 about?
NCT04566822 is a clinical study titled "Calm Sleep Coaching". The Centers for Disease Control and Prevention has identified insufficient sleep as a public health epidemic, with more than 70 million US adults experiencing insomnia each year. However, access to current evidence-based interventions for sleep disturbance (e.g., Cognitive Behavior Therapy for Insom...
What is the current status of trial NCT04566822?
This trial is currently completed. It is a NA study. The enrollment target is 388 participants. The study started on 2020-09-21. Estimated completion is 2020-12-22.
What conditions does trial NCT04566822 study?
This clinical trial studies the following conditions: Sleep Disturbance.
What interventions are being tested in trial NCT04566822?
The interventions under investigation include: High Touch intervention (BEHAVIORAL), Medium Touch intervention (BEHAVIORAL), Low Touch intervention (BEHAVIORAL), Sleep Education Control (BEHAVIORAL).
Who is sponsoring clinical trial NCT04566822?
This trial is sponsored by Arizona State University, which has 187 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04566822 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04566822's enrollment target sits among peer trials
388 6th of 56 higher than 51 of 56 other Sleep Disturbance trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sleep Disturbance 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.
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