Improving sleep quality in individuals with Down syndrome
Improving Sleep and Quality of Life in Individuals With Down Syndrome and Their Caregivers
This study is testing a new online program to help young people with Down syndrome sleep better and feel happier in their daily lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 12 Months to 30 Years |
| Sex | All |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 1 site (Birmingham, Alabama) |
| Trial ID | NCT06783725 on ClinicalTrials.gov |
What this trial studies
This project aims to adapt a virtual Mindfulness-Based Therapy for Insomnia (MBTI) specifically for individuals with Down syndrome aged 12-30 years. The intervention will be developed in collaboration with a community advisory board, ensuring it is relevant and engaging for participants. Key adaptations include the use of visual aids, shortened meditation practices, caregiver involvement, and modified session structures to enhance participation and effectiveness. The goal is to improve sleep quality and overall quality of life for both individuals with Down syndrome and their caregivers.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12-30 with a confirmed diagnosis of Down syndrome who experience sleep disturbances.
Not a fit: Patients with severe sensory or motor impairments that interfere with participation or those unable to complete assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance sleep quality and overall well-being for individuals with Down syndrome and their caregivers.
How similar studies have performed: While there is limited research specifically targeting sleep interventions in Down syndrome, mindfulness-based therapies have shown promise in other populations, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Birmingham, Alabama
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
Study contacts
- Principal investigator: Caroline G Richter, PhD — University of Alabama at Birmingham
- Study coordinator: Caroline G Richter, PhD
- Email: carolinerichter@uab.edu
- Phone: 205-934-9897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.