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NCT06783725 · ClinicalTrials.gov registry record · NA
Sleep Intervention and Quality of Life in Down Syndrome
A NA study of Down Syndrome and Down Syndrome (Trisomy 21), sponsored by University of Alabama at Birmingham.
- Recruiting
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06783725 is a NA study of Down Syndrome and Down Syndrome (Trisomy 21) that is actively recruiting participants, run by University of Alabama at Birmingham. The registered enrollment target is 20 participants, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06783725, a NA study of Down Syndrome and Down Syndrome (Trisomy 21), is actively recruiting participants, sponsored by University of Alabama at Birmingham.
- RECRUITING
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Aim 1 of the proposed project will be to adapt the virtual Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with Down syndrome (DS). The investigators will work closely with a community advisory board consisting of individuals with DS, their caregivers, and clinicians specializing in DS and sleep medicine to ensure that the intervention protocol is relevant and appropriate for young people with DS (age 12 and older). Planned adaptations include 1) utilization of visual aids and videos to increase engagement and reinforce mindfulness concepts and practices; 2) shortened meditation practices to accommodate concentration limits of individuals with DS; 3) caregiver involvement reflecting the important role of caregivers in daily functioning of individuals with DS; 4) adapted homework to cater to the learning styles of individuals with DS; 5) daily reminders to encourage regular practice and reinforce the importance of consistency; and 6) modified session structure to ensure that participants are able to discuss their experiences and refine their mindfulness practice. During the first 6 months of the project, the investigators will meet monthly with the community advisory board and use an iterative process to develop detailed intervention protocol for a virtual MBTI suitable for young people with DS. Aim 2 of the project will be to pilot test the efficacy of the virtual MBTI for young people with DS. In the second half of the one-year project, the investigators will conduct a pilot randomized clinical trial (RCT) of the intervention developed in Aim 1. This project will compare the effectiveness of Mindfulness Based Therapy for Insomnia (MBTI) and Brief Behavioral Therapy for Insomnia (BBTI) for young people with Down syndrome (DS). The interventions will be compared on their impact on improving sleep problems, quality of life, and functional outcomes. This project will also test if targeting the sleep of the caregiver in addition to the individual with Do
Conditions Studied
Interventions
- BEHAVIORAL Mindfulness-Based Therapy for Insomnia
- BEHAVIORAL Wait-list control
Study Locations (1)
Alabama
- University of Alabama at Birmingham - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-03-01 |
| Est. Completion | 2027-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06783725
The ClinicalTrials.gov registry entry for NCT06783725 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,471-participant average among 54 other Down Syndrome trials with a reported enrollment target (99% lower). The listed sponsor is University of Alabama at Birmingham, which has 1,160 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Down Syndrome appearing as the primary indexed condition, and to 2 interventions - of which Mindfulness-Based Therapy for Insomnia is the first listed.
NCT06783725 reports 1 study location spanning 1 distinct geographic area - top geographies include Alabama.
Frequently Asked Questions
What is clinical trial NCT06783725 about?
NCT06783725 is a clinical study titled "Sleep Intervention and Quality of Life in Down Syndrome". Aim 1 of the proposed project will be to adapt the virtual Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with Down syndrome (DS). The investigators will work closely with a community advisory board consisting of individuals with DS, their caregivers, and clinicians specializing in DS...
What is the current status of trial NCT06783725?
This trial is currently recruiting. It is a NA study. The enrollment target is 20 participants. The study started on 2025-03-01. Estimated completion is 2027-12-31.
What conditions does trial NCT06783725 study?
This clinical trial studies the following conditions: Down Syndrome, Down Syndrome (Trisomy 21).
What interventions are being tested in trial NCT06783725?
The interventions under investigation include: Mindfulness-Based Therapy for Insomnia (BEHAVIORAL), Wait-list control (BEHAVIORAL).
Who is sponsoring clinical trial NCT06783725?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06783725 being conducted?
This trial has 1 study location across Alabama. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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