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RECRUITINGNANCT06783725

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 a...

Lead sponsor: University of Alabama at Birmingham•1 U.S. locations•View source on ClinicalTrials.gov

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Contacts

Caroline G Richter, PhD

CONTACT

205-934-9897 carolinerichter@uab.edu

Sylvie Mrug, PhD

CONTACT

(205) 934-3850 sylva@uab.edu

Sponsors

Lead Sponsor

University of Alabama at Birmingham

This study aims to address the significant gap in effective behavioral treatments for sleep problems in individuals with Down syndrome (DS). Specifically, it focuses on testing the efficacy of a virtual Mindfulness-Based Therapy for Insomnia (MBTI) for individuals with DS aged 12-30 years, along with their caregivers. The intervention seeks to improve sleep quality and overall quality of life for both participants and their caregivers.

Age

1 - 30 years

Sex

ALL

Healthy Volunteers

No

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.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 20, 2026Terms

Trial snapshot

StatusRECRUITING

PhaseNA

Enrollment20

Start dateMar 2025

Last updatedMar 20, 2026

Condition

Down Syndrome Down Syndrome (Trisomy 21)

Locations shown

University of Alabama at Birmingham

Birmingham, Alabama

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 20, 2026Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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