RecruitingNot Applicable

MARPE-Associated Changes in Sleep and Airway

Turkey (Türkiye)40 participantsStarted 2025-05-30

Plain-language 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.

Who can participate

Age range

15 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: 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° Exclusion Criteria: Presence of systemic diseases Smoking Poor oral hygiene Lack of cooperation Mental retardation Obesity or nutritional disorders Macroglossia or mandibular retrognathia

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: 3 month

Trial details

NCT IDNCT07031349

SponsorKonya Necmettin Erbakan Üniversitesi

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-08-30

Contact for this trial

Seda Sağoğlu

+905354121271 ssagoglu@gmail.com

View on ClinicalTrials.gov More Rapid Maxillary Expansion trials