NCT06783725 Sleep Intervention and Quality of Life in Down Syndrome
| NCT ID | NCT06783725 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Alabama at Birmingham |
| Condition | Down Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 20 participants in total. It began in 2025-03-01 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Down syndrome has any effect on the outcomes.
Eligibility Criteria
Inclusion Criteria: * Individuals with a confirmed diagnosis of Down syndrome (DS). * English is the primary language spoken in the household. * Nonverbal mental age of at least 36 months, as determined by a baseline measure of adaptive skills. * Presence of at least one sleep disturbance occurring five or more nights per week, as reported by a caregiver. Sleep disturbances may include: Bedtime resistance; Delayed sleep onset; Problematic sleep associations; Nighttime awakenings; Early morning awakenings Exclusion Criteria: * Severe sensory or motor impairments that would interfere with participation in the intervention. * Inability to complete assessments or participate in the intervention sessions due to behavioral or medical conditions. * Participation in other concurrent behavioral or sleep interventions. * Caregiver inability or unwillingness to provide accurate reports or assist in intervention activities as needed.
Contact & Investigator
Caroline G Richter, PhD
PRINCIPAL INVESTIGATOR
University of Alabama at Birmingham
Frequently Asked Questions
Who can join the NCT06783725 clinical trial?
This trial is open to participants of all sexes, aged 12 Months or older, up to 30 Years, studying Down Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06783725 currently recruiting?
Yes, NCT06783725 is actively recruiting participants. Contact the research team at carolinerichter@uab.edu for enrollment information.
Where is the NCT06783725 trial being conducted?
This trial is being conducted at Birmingham, United States.
Who is sponsoring the NCT06783725 clinical trial?
NCT06783725 is sponsored by University of Alabama at Birmingham. The principal investigator is Caroline G Richter, PhD at University of Alabama at Birmingham. The trial plans to enroll 20 participants.