MARPE-Associated Changes in Sleep and Airway
ConditionRapid Maxillary Expansion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-18
SponsorKonya Necmettin Erbakan Üniversitesi
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Single group
Treatments tested in this trial
MARPE
DeviceAdult patients with maxillary constriction underwent maxillary expansion using a miniscrew-assisted rapid palatal expander (MARPE).
Treatment groups
40 Participants
are divided into 1 treatment groupGroup A: MARPEOther 1 intervention
Trial outcomes
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.
Time frame
3 monthSponsors and contacts
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Source ClinicalTrials.gov