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Sleep Intervention and Quality of Life in Down Syndrome Study

This study is testing a program called Mindfulness-Based Therapy for Insomnia (MBTI) to help people with Down syndrome improve their sleep. MBTI is a structured program that uses mindfulness practices, thinking strategies, and sleep education. The study wants to see if MBTI can improve sleep quality and overall quality of life for individuals with Down syndrome and their caregivers. You might be able to join if you are between 12 months and 30 years old, have Down syndrome, speak English at home, and have a caregiver reporting sleep problems at least five nights a week. The study will measure how long you sleep, how well you sleep (sleep efficiency), and how many times you wake up at night. The current status of the study is unclear.

Study design
This interventional study plans to enroll 20 participants. It compares Mindfulness-Based Therapy for Insomnia (MBTI) to a wait-list control group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Sleep quality will be measured before the intervention and at week 9, which is the end of the 8-week intervention period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06783725

Sleep Intervention and Quality of Life in Down Syndrome

Recruiting
NAAges 12–30InterventionalTreatment
University of Alabama at Birmingham
~20 participants
Updated 2026-03-20 on ClinicalTrials.gov
What's tested:Mindfulness-Based Therapy for InsomniaWait-list control

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective Sleep Quality - Sleep duration
Measured over Before (week 0) and at week 9 (the end of the 8-week intervention period).
+4 more outcomes measured

Conditions

Down Syndrome
Down Syndrome (Trisomy 21)

Explore related trials

Down Syndrome

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • Caroline G Richter, PhD · PRINCIPAL_INVESTIGATOR · University of Alabama at Birmingham

Who to contact

Caroline G Richter, PhD
[email protected]
205-934-9897
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Objective Sleep Quality - Sleep durationBefore (week 0) and at week 9 (the end of the 8-week intervention period).

    Assessed using wearable devices (FitBit Versa 4), which record sleep parameters: Sleep duration (in hours). Sleep duration in hours will be averaged over seven consecutive days, before and after the 8-week intervention. Higher scores indicate better outcome.

  • Objective Sleep Quality - Sleep efficiencyBefore (week 0) and at week 9 (the end of the 8-week intervention period).

    Assessed using wearable devices (FitBit Versa 4), which record sleep parameters: Sleep efficiency (percentage of time spent asleep while in bed). Higher scores indicate better outcome.

  • Objective Sleep Quality - Number of night awakeningsBefore (week 0) and at week 9 (the end of the 8-week intervention period).

    Assessed using wearable devices (FitBit Versa 4), which record sleep parameters: Number of night awakenings (count for night awakenings)

  • Subjective Sleep Quality - Children's Sleep Habits QuestionnaireBefore (week 0) and at week 9 (the end of the 8-week intervention period).

    Measured using standardized parent-reported questionnaires: \- Children's Sleep Habits Questionnaire (CSHQ): Assesses sleep behaviors and patterns. The CSHQ is a retrospective, 45-item parent questionnaire. Scale Range: 45-135. Higher scores indicate worse sleep quality. Unit of Measure: Raw score

  • Subjective Sleep Quality - Insomnia Severity IndexBefore (week 0) and at week 9 (the end of the 8-week intervention period).

    \- Insomnia Severity Index (ISI): Measures the severity of insomnia symptoms. Scale Range: 0-28. Higher scores indicate worse insomnia severity.