MARPE-Associated Changes in Sleep and Airway

NCT07031349 | Recruiting

• 1 other identifier: 2025/596
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

At the beginning of MARPE treatment (T1) and at the end of the 3-month consolidation phase (T2), patients will complete the teen-STOP-BANG questionnaire and the Pittsburgh Sleep Quality Index (PSQI) to assess the potential benefit of MARPE in reducing the risk of obstructive sleep apnea syndrome (OSAS). Additionally, changes in the upper airway will be evaluated using CBCT images obtained at T1 and T2.

Conditions

Rapid Maxillary Expansion

Keywords

MARPE; STOP-BANG; PSQI

Outcome Measures

Primary Outcomes (1)

• Change in obstructive sleep apnea (OSA) risk as measured by the teen-STOP-BANG questionnaire

  The teen-STOP-BANG questionnaire will be used to assess changes in OSA risk following MARPE treatment. STOP-BANG scores range from 0 to 8; a score of at least 3 indicates that the patient is at risk of OSAHS, and a score of at least 5 indicates that the patient is at high risk of OSA.

  3 month

Study Arms (1)

MARPE

OTHER

Adult individuals treated with miniscrew-assisted rapid palatal expansion (MARPE)

Device: MARPE

Interventions

MARPE DEVICE

Adult patients with maxillary constriction underwent maxillary expansion using a miniscrew-assisted rapid palatal expander (MARPE).

MARPE

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Class I malocclusion Maxillary transverse deficiency Age between 15 and 18 years No systemic disease, cleft lip and palate, or speech disorders No history of prior orthodontic treatment Voluntary agreement to participate in the study Good oral hygiene ANB angle between 2° and 5°

You may not qualify if:

• Presence of systemic diseases Smoking Poor oral hygiene Lack of cooperation Mental retardation Obesity or nutritional disorders Macroglossia or mandibular retrognathia

Sponsors & Collaborators

• Konya Necmettin Erbakan Üniversitesi: lead

Study Sites (1)

Necmettin Erbakan University

Konya, Meram, 42090, Turkey (Türkiye)

RECRUITING

Related Links

• Effect of surgically assisted rapid maxillary expansion on obstructive sleep apnea.

Central Study Contacts

Seda Sağoğlu

CONTACT

+905354121271; ssagoglu@gmail.com

Kazım K YILDIZ

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: June 11, 2025
• First Posted: June 22, 2025
• Study Start: May 30, 2025
• Primary Completion: August 30, 2025
• Study Completion: September 5, 2025
• Last Updated: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)