By InvitationNot Applicable

Impact of Palatal Expansion and Up-Locker Activator on Sleep and Pharyngeal Dimensions in Children

Colombia34 participantsStarted 2024-08-21

Plain-language summary

Objective: The study will aim to compare the effect of palatal expansion with Hyrax and Hyrax combined with Up-Locker on sleep behavior, sleep architecture, quality of life and nasal and pharyngeal airway dimensions, as well as intermolar, intercanine, and palatal depth dimensions in children. Materials and Methods: This prospective, single-blind, randomized controlled clinical trial will enroll 34 children aged 6-8 years, who will be randomly assigned to receive treatment with either the Hyrax expansion appliance alone or in combination with the Up-Locker vacuum activator. Intercanine, intermolar, and palatal depth dimensions will be evaluated through intraoral scans. Airway dimensions will be assessed using panoramic and lateral cephalometric radiographs, while sleep behavior will be analyzed with the Children's Sleep Habits Questionnaire (CSHQ) and sleep architecture will be evaluated via polysomnography. Data will be analyzed using the Shapiro-Wilks test for homogeneity, and comparisons will be performed with either the t-test or the Mann-Whitney U test. Results: It is expected that intercanine and intermolar distances will improve in both the Hyrax and Hyrax combined with Up-Locker vacuum activator groups after treatment, while palatal depth will present a significant reduction only in the group receiving Hyrax with Up-Locker. The group using the Hyrax combined with Up-Locker vacuum activator will likely experience more significant improvements in sleep latency, total sleep time, REM sleep, and arousal indices compared to the Hyrax group (p\<0.05) after treatment. Both groups are anticipated to demonstrate reduction of snoring, enhanced airway dimensions post-treatment, including the area of the nostrils and the naso and oropharynx. Conclusion: It is expected that combined treatment with Hyrax and Up-Locker vacuum activator will yield superior outcomes in sleep architecture, intraoral dimensions, and airway dimensions.

Who can participate

Age range

6 Years – 8 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * The Inclusion Criteria will include the presence of sleep-disordered breathing symptoms with a minimum score of 6 on the Children's Sleep Habits Questionnaire (CSHQ), documented snoring recorded by SnoreLab® for at least five consecutive days, and transverse maxillary deficiency of at least 5 mm, with a normal superior intermolar distance defined as a minimum of 40 mm (measured between the mesiopalatine cusps of teeth 16 and 26). Exclusion Criteria: * The exclusion criteria for this study will include a history of previous treatment for OSA (including tonsillectomy and adenoidectomy), being overweight or obese (Body Mass Index (BMI) at or above the 85th percentile for their age and sex), chronic systemic diseases unrelated to upper airway respiratory alterations (e.g., chronic cardiopulmonary or neuromuscular diseases), facial malformations (e.g., syndromes with facial or cleft lip/palate anomalies, or clinically evident palatal malformations), presence of dental caries, previous treatment with maxillary orthopedics or orthodontics, and failure to comply with scheduled control visits.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Sleep behavior

Timeframe: From enrollment to the end of treatment at 9 months

Sleep architecture

Timeframe: From baseline to the end of treatment at 9 months

Pharynx dimensions

Timeframe: From baseline to the end of treatment at 9 months

Trial details

NCT IDNCT06986343

SponsorCES University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Breathing Disorder During Sleeping trials