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NCT Number: NCT06783725

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 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.

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Key information

Conditions

Down Syndrome Abnormalities, Multiple Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Down Syndrome (Trisomy 21) Genetic Diseases, Inborn Intellectual Disability Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations

Age range

12 month–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Caroline G Richter, PhD

CONTACT

[email protected]

205-934-9897

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness-Based Therapy for Insomnia

Behavioral

Mindfulness-based therapy for insomnia (MBTI) is a structured program designed to help individuals with chronic insomnia improve their sleep patterns through mindfulness practices. It combines mindfulness meditation, cognitive behavioral strategies, and sleep education to address the cognitive and physiological factors that disrupt sleep. The therapy emphasizes present-moment awareness, acceptance of sleep difficulties, and the reduction of sleep-related anxiety to promote better sleep quality and overall well-being.

Wait-list control

Behavioral

The wait-list control group consists of participants who do not receive the intervention during the initial study period but are placed on a waitlist to receive it after the trial concludes. This group serves as a comparison to evaluate the effectiveness of the intervention while ensuring participants eventually have access to the treatment. It helps control for natural changes over time and the psychological effects of expecting future treatment.

Primary outcomes

  1. Objective Sleep Quality - Sleep duration

    Time frame: Before (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.

  2. Objective Sleep Quality - Sleep efficiency

    Time frame: Before (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.

  3. Objective Sleep Quality - Number of night awakenings

    Time frame: Before (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)

  4. Subjective Sleep Quality - Children's Sleep Habits Questionnaire

    Time frame: Before (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

  5. Subjective Sleep Quality - Insomnia Severity Index

    Time frame: Before (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.

Secondary outcomes

  1. Quality of life - Caregiver report

    Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).

    Quality of life is a secondary outcome variable, evaluated using caregiver-reported measures: 1) Pediatric Quality of Life Inventory (PedsQL): Assesses health-related quality of life across physical, emotional, social, and school functioning domains. Scale Range: 0-100. Higher scores indicate better quality of life. Changes in scores before and after the intervention will be compared to evaluate improvements in quality of life.

  2. Quality of life

    Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).

    Quality of life is a secondary outcome variable, evaluated using caregiver-reported measures:

    • KidsLife: Measures quality of life specific to individuals with developmental disabilities, including participation and independence. Scale Range: 0-100. Higher scores indicate better quality of life.

  3. Quality of life

    Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).

    Quality of life is a secondary outcome variable, evaluated using caregiver-reported measures:

    • KIDSCREEN-27: Evaluates physical well-being, psychological well-being, autonomy, social support, and peer relationships. Scale Range: 0-100. Higher scores indicate better quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline G Richter, PhD

CONTACT

[email protected]

205-934-9897

Sylvie Mrug, PhD

CONTACT

[email protected]

(205) 934-3850

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Improving Sleep and Quality of Life in Individuals With Down Syndrome and Their Caregivers

Acronym: SleepDS

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 20, 2025
Registry last updated
Mar 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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