Down SyndromeSleepDSNCT06783725
Sleep Intervention and Quality of Life in Down Syndrome
A study testing Mindfulness-Based Therapy for Insomnia in people with Down Syndrome and Down Syndrome (Trisomy 21), run by University of Alabama at Birmingham at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 months to 30 years
- Conditions the study is for
- Down Syndrome, Down Syndrome (Trisomy 21)
- What is being tested?
- Mindfulness-Based Therapy for Insomnia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 months to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Caroline G Richter, PhD, 205-934-9897, carolinerichter@uab.edu
About this study
Official title: Improving Sleep and Quality of Life in Individuals With Down Syndrome and Their Caregivers
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.
Read the 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.
- Conditions
- Down Syndrome, Down Syndrome (Trisomy 21)
- Being tested
- Mindfulness-Based Therapy for Insomnia, Wait-list control
- Keywords
- Down syndrome, sleep, Mindfulness-Based Therapy for Insomnia
- Medical subject headings
- Down Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Therapy for InsomniaBehavioural
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 controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Therapy for Insomnia | Experimental | Individuals with Down syndrome will receive the MBTI intervention over 8 sessions lasting 1 hour over 8 weeks (one session per week). One trained graduate research assistant will deliver the intervention with supervision of a licensed Clinical Psychologist. Receives: Behavioral: Mindfulness-Based Therapy for Insomnia |
| Wait-list control | Placebo comparator | The control group will do the pre and post assessments but will not be part of any intervention. The wait-list control group will receive the MBTI intervention after the post-intervention measures are completed. Receives: Behavioral: Wait-list control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Sleep Quality - Sleep duration
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.
Measured: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Objective Sleep Quality - Sleep efficiency
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.
Measured: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Objective Sleep Quality - Number of night awakenings
Assessed using wearable devices (FitBit Versa 4), which record sleep parameters: Number of night awakenings (count for night awakenings)
Measured: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Subjective Sleep Quality - Children's Sleep Habits Questionnaire
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
Measured: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Subjective Sleep Quality - Insomnia Severity Index
- Insomnia Severity Index (ISI): Measures the severity of insomnia symptoms. Scale Range: 0-28. Higher scores indicate worse insomnia severity.
Measured: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Secondary outcomes (3)
Quality of life - Caregiver report
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.
Measured: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Quality of life
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.
Measured: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Quality of life
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.
Measured: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Mar 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Down SyndromeStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caroline G. Richter, University of Alabama at Birmingham
- Investigators
- Caroline G Richter, PhD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783725
- Sponsor's protocol ID
- IRB-300013331
- Other IDs
- 3128827.000.213128827.48160000
- Acronym
- SleepDS
- Status last verified
- Mar 2026
- First submitted
- 27 Dec 2024
- Last updated
- 20 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Sleep and Quality of Life in Individuals With Down Syndrome and Their Caregivers
- ClinicalTrials.gov ID
- NCT06783725
- Acronym / sponsor ID
- SleepDS / IRB-300013331
- Conditions
- Down Syndrome, Down Syndrome (Trisomy 21)
- Keywords
- Down syndrome, sleep, Mindfulness-Based Therapy for Insomnia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Therapy for Insomnia | Experimental | Behavioral: Mindfulness-Based Therapy for InsomniaIndividuals with Down syndrome will receive the MBTI intervention over 8 sessions lasting 1 hour over 8 weeks (one session per week). One trained graduate research assistant will deliver the intervention with supervision of a licensed Clinical Psychologist. |
| Wait-list control | Placebo comparator | Behavioral: Wait-list controlThe control group will do the pre and post assessments but will not be part of any intervention. The wait-list control group will receive the MBTI intervention after the post-intervention measures are completed. |
Who may qualify
- Ages
- 12 months to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Therapy for InsomniaMindfulness-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. | Behavioural | Mindfulness-Based Therapy for Insomnia |
| Wait-list controlThe 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. | Behavioural | Wait-list control |
Primary outcome
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.
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.
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)
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
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.
3 secondary outcomes
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
Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Quality of life
Time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Caroline G Richter, PhD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Therapy for Insomnia in people with Down Syndrome and Down Syndrome (Trisomy 21), run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline G Richter, PhD (205-934-9897, carolinerichter@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Sleep Quality - Sleep duration (time frame: Before (week 0) and at week 9 (the end of the 8-week intervention period).). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.