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NCT04920630 · ClinicalTrials.gov registry record · NA
TRAIN Your Sleep; Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)
A NA study, sponsored by Indiana University.
- Terminated
- Registry status
- NA
- Development phase
- 26
- Enrollment target
NCT04920630: Clinical Trial NA study, sponsored by Indiana University.
NCT04920630 is a NA study that was terminated before completion, run by Indiana University. The registered enrollment target is 26 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04920630, a NA study, was terminated before completion, sponsored by Indiana University.
- TERMINATED
- Registry status
- NA
- Development phase
- 26 participants
- Enrollment target
Study Summary
The primary aim of this study is to understand how insomnia contributes to chronic pain in youth. Specifically, the investigators are interested in how insomnia and the treatment of insomnia impact emotional states and the body's ability to efficiently modulate pain, either to increase or decrease pain perception. It is hypothesized that insomnia is associated with increased negative emotional states and impaired pain modulation, which will improve after treatment of insomnia. In this project, the objectives are to 1) evaluate the role of pain modulation as a potential mechanism through which insomnia impacts pain symptoms, and 2) evaluate the role of negative affect as mediators of the impact of insomnia on pain modulation. Study participation will consist of a baseline assessment, a 5 session (once per week) virtual group cognitive behavioral therapy for insomnia (CBT-I) intervention, and a follow-up assessment. Investigators will also ask teen participants to complete the consensus sleep diary daily for 7 days prior to the baseline and follow up study visits. Assessment visits will consist of two types of assessments, questionnaires and quantitative sensory testing (QST). Participating parents and teens will complete questionnaires (both child and parent report) assessing the child's pain, sleep, and psycho-social variables. QST will assess pain inhibition via conditioned pain modulation (CPM) and pain facilitation via temporal summation (TS).
Primary Outcome
Heat pain threshold (test stimulus) will be assessed on the volar surface of the dominant forearm twice before before, during, and after immersion (for 1 minute) of the non-dominant hand in a circulated cold-water bath (conditioning stimulus) maintained at 5˚C ±1˚C. Heat pain threshold will be assessed via the method of limits. Subjects will be instructed to push a button as soon as the heat feels painful, which will stop the trial. Immediately before and after the CPM assessment, the subjects'
Interventions
- BEHAVIORAL Cognitive Behavioral Therapy - Insomnia (CBT-I)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-05-10 |
| Est. Completion | 2023-05-05 |
| Phase | NA |
Why NCT04920630 stopped before completion
NCT04920630 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Cognitive Behavioral Therapy - Insomnia (CBT-I) is the first listed.
NCT04920630 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04920630 about?
NCT04920630 is a clinical study titled "TRAIN Your Sleep; Treating Adolescent Insomnia With Cognitive Behavioral Therapy for Insomnia (CBT-I)". The primary aim of this study is to understand how insomnia contributes to chronic pain in youth. Specifically, the investigators are interested in how insomnia and the treatment of insomnia impact emotional states and the body's ability to efficiently modulate pain, either to increase or decrease p...
What is the current status of trial NCT04920630?
This trial is currently terminated. It is a NA study. The enrollment target is 26 participants. The study started on 2021-05-10. Estimated completion is 2023-05-05.
What interventions are being tested in trial NCT04920630?
The interventions under investigation include: Cognitive Behavioral Therapy - Insomnia (CBT-I) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04920630?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04920630's enrollment target sits among peer trials
26 1710th of 2000 higher than 289 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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