Status:
ENROLLING_BY_INVITATION
Impact of Palatal Expansion and Up-Locker Activator on Sleep and Pharyngeal Dimensions in Children
Lead Sponsor:
CES University
Conditions:
Breathing Disorder During Sleeping
Sleep Habits
Eligibility:
All Genders
6-8 years
Phase:
NA
Brief 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 ai...
Detailed Description
This investigation was approved by the ethics committee of Universidad CES, and the parents will provide their written informed consent while the children will give their written assent. A prospective...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT06986343
Start Date
August 21 2024
End Date
June 1 2025
Last Update
May 23 2025
Active Locations (1)
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1
Dentistry Faculty
Medellín, Antioquia, Colombia, 055420