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

NCT06986343 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: CES1198
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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 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

Keywords

Palatal expansion; Up-Locker vacuum activator; polysmonography; airway; Hyrax; Children

Outcome Measures

Primary Outcomes (3)

• Sleep behavior

  Sleep behavior will be assessed using the validated CSHQ, which is a 35-item questionnaire that will be administered to parents, asking them to report their child's sleep behaviors and patterns during the last typical week. The questionnaire will be developed to address significant clinical sleep complaints commonly observed in this age group and will provide data on the following subscales (with score ranges in parentheses): Bedtime Resistance (6-36), Sleep Onset Delay (1-3), Sleep Duration (3-9), Sleep Anxiety (4-12), Night Awakenings (3-9), Parasomnias (7-21), Sleep Disordered Breathing (3-9), and Daytime Sleepiness (8-24). Each item on the questionnaire will be rated on a three-point scale: "usually" (5-7 times a week) = 3, "sometimes" (2-4 times a week) = 2, and "rarely" (0-1 time a week) = 1. A composite score will be computed as the sum of scores on the 33 items across all subscales.

  From enrollment to the end of treatment at 9 months

• Sleep architecture

  Sleep architecture would be assessed with polysomnography All children in the control and the intervention group will undergo a one-night PSG study in a sleep laboratory in Medellín, Colombia, before treatment (T0) and at the end of treatment for the intervention group (T1, nine months after the beginning of treatment for both groups). The sleep study will utilize a sleep recording system and dedicated scoring software (Neuron-Spectrum-65/PSG system™, Neurosoft Ltd. Ivanova, Russia). The measurements will be made between 9:00 pm and 6:00 am for all participants. Audio and video signals will be recorded in parallel. A nasal flow cannula and a thermistor respiratory monitor will record respiration, and a finger pulse oximeter will monitor blood oxygen saturation (SaO2). A trained research team will install all electrodes and sensors. The sleep architecture will be evaluated according to the AASM Manual for the Scoring of Sleep and Associated Events.

  From baseline to the end of treatment at 9 months

• Pharynx dimensions

  Dimensions of the naropharynx and oropharynx are going to be measured in lateral cephalic x-rays.

  From baseline to the end of treatment at 9 months

Study Arms (2)

Group 1. Hyrax

ACTIVE COMPARATOR

Children in the control group will have treatment with a semi-rapid maxillary expansion (SRME) with a Hyrax device with a Leone™ standard expansion screw. Bands will be placed on the maxillary first permanent molars, and a frame containing the maxillary canines and primary first molars will be used to support the expander. The same expert technician will construct all expanders. In both groups, the expander screw will be activated a quarter turn twice a day for the first 7 days, then once a day until the palatal cusp of the upper molar comes into contact with the buccal cusp of the lower molar. After the active phase, the expanders will be maintained in the oral cavity for 4 months for retention.

Device: Hyrax

Group 2. Hyrax + Uplocker vacuum activator

EXPERIMENTAL

The patients in the intervention group (Hyrax+Up-locker vacuum activator) will receive a standardized training device (Up-Locker Vacuum Activator from Forwardontics™, approved by the FDA) immediately after finishing the retention period and retiring the expansion Hyrax device. Following instruction, the patients will undergo 30 minutes of daily home training in the first week, 60 minutes of daily home training in the second and third weeks, and thereafter 120 minutes of daily home training until completion of a 90-day program.

Device: Hyrax and Uplocker Vacuum Device

Interventions

Hyrax DEVICE

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

Group 1. Hyrax

Hyrax and Uplocker Vacuum Device DEVICE

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

Group 2. Hyrax + Uplocker vacuum activator

Eligibility Criteria

• Age: 6 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

Sponsors & Collaborators

• CES University: lead

Study Sites (1)

Dentistry Faculty

Medellín, Antioquia, 055420, Colombia

Location

Related Publications (3)

• Owens JA, Spirito A, McGuinn M. The Children's Sleep Habits Questionnaire (CSHQ): psychometric properties of a survey instrument for school-aged children. Sleep. 2000 Dec 15;23(8):1043-51.

  PMID: 11145319 BACKGROUND

• Dutil C, Walsh JJ, Featherstone RB, Gunnell KE, Tremblay MS, Gruber R, Weiss SK, Cote KA, Sampson M, Chaput JP. Influence of sleep on developing brain functions and structures in children and adolescents: A systematic review. Sleep Med Rev. 2018 Dec;42:184-201. doi: 10.1016/j.smrv.2018.08.003. Epub 2018 Aug 15.

  PMID: 30241996 BACKGROUND

• Restrepo C, Kahn S, Gozal D. Impact of Palatal Expansion With Up-Locker on Children With Sleep-Disordered-Breathing: A Clinical Trial. Pediatr Pulmonol. 2026 Jan;61(1):e71424. doi: 10.1002/ppul.71424.

  PMID: 41521856 DERIVED

MeSH Terms

Conditions

Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Claudia C Restrepo-Serna, PhD

  CES University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD. Director CES-LPH Research Group

Model Details: A prospective, single-blind, randomized controlled clinical trial will be performed. Children aged 6 to 8 years, recruited from the clinics of the postgraduate program of Pediatric Dentistry and the private practice of one of the investigators (CR), will be included. The sample size was calculated based on the differences reported by Sökücü et al. Assuming a 95% confidence level, 80% power, and a 20% treatment difference, 17 participants per group (total n = 34) will be required. No additional oversampling will be planned due to ethical considerations regarding radiation exposure. The inclusion criteria will include the presence of sleep-disordered breathing symptoms with a minimum score of 6 on the Spanish version of the Children's Sleep Habits Questionnaire (CSHQ), documented snoring recorded by RONCOLAB® for at least five consecutive days, and transverse maxillary deficiency of at least 5 mm, defined as a superior intermolar distance of le

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: May 23, 2025
• Study Start: August 21, 2024
• Primary Completion: May 31, 2025
• Study Completion: June 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Locations

CO (1)