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

NCT06986343 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-05-23

No results posted yet for this study

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.

Conditions

  • Breathing Disorder During Sleeping
  • Sleep Habits

Interventions

DEVICE

Hyrax

Children in this group are going to use only the Hyrax device.

DEVICE

Hyrax and Uplocker Vacuum Device

Children in this group are going to use the Hyrax device and Up-Locker vacuum activator.

Sponsors & Collaborators

  • CES University

    lead OTHER

Principal Investigators

  • Claudia C Restrepo-Serna, PhD · CES University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-21
Primary Completion
2025-05-31
Completion
2025-06-01
FDA Device
Yes

Countries

  • Colombia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06986343 on ClinicalTrials.gov