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Down Syndrome clinical trials

View clinical trials related to Down Syndrome.

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NCT ID: NCT05508971 Enrolling by invitation - Clinical trials for Obstructive Sleep Apnea

Treatment of Obstructive Sleep Apnea With Personalized Surgery in Children With Down Syndrome (TOPS-DS)

TOPS-DS
Start date: August 23, 2023
Phase: N/A
Study type: Interventional

The overall objective of this randomized clinical trial is to test the effectiveness of a personalized approach to the surgical treatment of OSA in children with Down syndrome (DS).The estimated prevalence of obstructive sleep apnea (OSA) in children with DS ranges from 45-83%, compared to 1-6% in the general pediatric population. Untreated OSA in children has been associated with daytime sleepiness, cognitive or behavioral problems, and cardiovascular complications, all which are common in children with DS. Adenotonsillectomy (AT) is the first line treatment for OSA in children, however, most large studies of AT outcomes have excluded children with DS. Available evidence demonstrates that AT is far less effective in children with DS than in the general pediatric population, with 48 to 95% of children with DS having persistent OSA after AT. Medical treatments such as positive airway pressure (PAP) therapy are frequently inadequate or poorly tolerated in this population, so many children with DS and OSA remain untreated. Drug-induced sleep endoscopy (DISE) enables direct observation of the sites and patterns of obstruction during sedated sleep using a flexible endoscope passed through the nose into the pharynx. DISE was developed to guide surgical decisions in adult OSA, and in recent years has also been used to design personalized surgical interventions in children. Using this DISE Rating Scale, the investigators have demonstrated that children with DS are more prone to tongue base and supraglottic obstruction than non-DS children, suggesting the need for more personalized surgical treatments that are tailored to the common sources of obstruction in this population. Several small case series demonstrate that DISE-directed surgery can be effective in treating OSA in children with DS. However, because there have been few prospective studies and no randomized trials comparing different treatment options in this population, there remains uncertainty about whether such a personalized approach leads to superior outcomes compared to the first line AT. It is the investigators' hypothesis that personalized DISE-directed surgery that uses existing procedures to address specific fixed and dynamic anatomic features causing obstruction in each child with DS will be superior to the current first line approach of AT. This novel approach may improve OSA outcomes and reduce the burden of unnecessary AT or secondary surgery for persistent OSA after an ineffective AT.

NCT ID: NCT05492981 Active, not recruiting - Down Syndrome Clinical Trials

Does an Educational Video for Aneuploidy Screening Improve Informed Choice Among Pregnant Women?

EVA
Start date: July 5, 2021
Phase: N/A
Study type: Interventional

Informed decision-making regarding aneuploidy screening has been reported to be low. Poor knowledge and the lack of deliberation have been cited as reasons for uninformed choices, highlighting the need for adequate pre-test counselling. We conducted a study to assess if an educational video improves informed choice in a clinical setting where both the combined first trimester screen and non-invasive prenatal screening are offered routinely to pregnant women.

NCT ID: NCT05482334 Recruiting - Down Syndrome Clinical Trials

Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome

Start date: October 23, 2023
Phase: Phase 2
Study type: Interventional

This trial protocol is designed to evaluate primarily whether the use of sargramostim (recombinant human GM-CSF), administered five days per week for four consecutive weeks (20 treatment days), will be well tolerated by and safe for use in young adult participants with Down syndrome.

NCT ID: NCT05473247 Not yet recruiting - Physical Inactivity Clinical Trials

GameSquad for Adults With Down Syndrome

Start date: January 15, 2023
Phase: N/A
Study type: Interventional

The investigators are assessing acceptability, appropriateness, and feasibility of the adapted GameSquad-DS intervention using validated scales alongside qualitative data among young adults with Down Syndrome. Specifically, the investigators will assess mins/wk of Ring-Fit Adventure played, attendance at 30 min. virtual health coaching sessions, semi-structured interviews, participant retention, and intervention safety measured as number of adverse events.

NCT ID: NCT05462106 Recruiting - Alzheimer's Disease Clinical Trials

A Study to Assess the Effects of ACI-24.060 in Alzheimer's Disease and in Down Syndrome (ABATE Study)

Start date: June 21, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the safety, tolerability, immunogenicity and pharmacodynamic effects of ACI-24.060 in subjects with prodromal Alzheimer's disease and in non-demented adults with Down syndrome.

NCT ID: NCT05460910 Recruiting - Down Syndrome Clinical Trials

Effects of Core Stability Exercises With and Without Treadmill Training on Balance in Children With Down Syndrome

Start date: May 18, 2022
Phase: N/A
Study type: Interventional

To find the effects of core stability exercises with and without treadmill training on balance in children with down syndrome

NCT ID: NCT05458479 Recruiting - Depression Clinical Trials

Fluoxetine Treatment of Depression in Down Syndrome

Start date: December 5, 2022
Phase: Phase 4
Study type: Interventional

The purpose of the study is to do a preliminary assessment of whether fluoxetine is effective, safe, and tolerable for the treatment of depression in adults with Down syndrome.

NCT ID: NCT05392322 Recruiting - Down's Syndrome Clinical Trials

Effect of Virtual Video Reality Gaming on Fine Motor Skills in Children With Down's Syndrome

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

Down's syndrome is genetic disorder caused by trisomy 21. Children with Down's syndrome are characterized by awkward movements, gait, increased flexibility of joints, timing of mastering of basic skills, under development of fine motor skills. Virtual Reality Therapy (VRT) is a technique that uses interactive games as a physical therapy resource and has shown positive results in cortical reorganization, improving functional mobility, and quality of movement. This is an experimental study in which randomized controlled trials study design is being used.

NCT ID: NCT05392309 Completed - Down S Syndrome Clinical Trials

Manual Ankle Rocking Training on Postural Control and Foot Function in Children With Down Syndrome

Start date: March 15, 2022
Phase: N/A
Study type: Interventional

Down syndrome occurs due to abnormal cell division of extra chromosome 21. It is a genetic disorder that causes postural un stability, leads to poor foot function and causes them difficulty that they can't fulfill their daily life activities and can't be independent. Strengthening exercise of lower limb and core strengthening of trunk muscle will provide postural stability and lower limb strengthening. Aim of this research is to determine the effects of manual Ankle rocking training on postural control and foot function in children with Down syndrome. Those who are diagnosed with down syndrome and are between age 8-15 and both of the genders are included in this research and those who have any surgical issue, visual impairment and musculoskeletal contractures are not included in the study we will use static standing balance test to check postural control and foot function index for Ankle rocking training from two group in which one will be given the baseline treatment of lower limb exercise and core strengthening with ankle rocking training and the other group without ankle rocking training and then the collected data will be analyzed by SPSS. 22

NCT ID: NCT05343468 Completed - Quality of Life Clinical Trials

Life Skills Improved in Children With Down Syndrome After Using Assistive Technology

Start date: September 20, 2020
Phase: N/A
Study type: Interventional

Enhancing independence and quality of life are key modifiable outcomes that are short- and long-term goals for children with Down syndrome (DS) and for their parents. The study investigated the efficacy of assistive technology in improving children with Down Syndrome's independence and quality of life. Using a commercially available assistive technology, the MapHabit system, the investigators implemented the software with participants' families for 4 weeks. The investigators hypothesized that the assistive technology will improve adaptive behavioral skills and overall quality of life.