Clinical trial NCT06783725: Sleep Intervention and Quality of Life in Down Syndrome
Official title: Improving Sleep and Quality of Life in Individuals with Down Syndrome and Their Caregivers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Down Syndrome
Down Syndrome (Trisomy 21)
Keywords: Down syndrome
sleep
Mindfulness-Based Therapy for Insomnia
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2025-01-20
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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.

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.

Primary outcomes:
measure: Objective Sleep Quality - Sleep duration
timeFrame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
measure: Objective Sleep Quality - Sleep efficiency
timeFrame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
measure: Objective Sleep Quality - Number of night awakenings
timeFrame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
measure: Subjective Sleep Quality - Children's Sleep Habits Questionnaire
timeFrame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
measure: Subjective Sleep Quality - Insomnia Severity Index
timeFrame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Secondary outcomes:
measure: Quality of life - Caregiver report
timeFrame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
measure: Quality of life
timeFrame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
measure: Quality of life
timeFrame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Caroline G Richter, PhD
role: PRINCIPAL_INVESTIGATOR
References: