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 range6 Years – 8 Years

SexALL

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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.

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