CompletedNot Applicable

Sagittal Malocclusion and Sleep Quality in Children

Turkey (Türkiye)164 participantsStarted 2021-04-01

Plain-language summary

This observational cross-sectional study evaluated the impact of sagittal skeletal malocclusions on sleep quality in children without orofacial functional disorders. A total of 164 children aged 7-13 years were assessed. Sleep quality was measured using the Children's Sleep Habits Questionnaire (CSHQ), and participants were classified as skeletal Class I, II, or III based on cephalometric analyses. Comparisons were made between skeletal groups regarding CSHQ scores, mandibular and vertical skeletal measurements, and upper airway dimensions. The aim was to determine whether skeletal discrepancies independently influence pediatric sleep quality in the absence of functional impairments.

Who can participate

Age range

7 Days – 13 Days

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: Children aged 7-13 years Presence of skeletal Class I, II, or III malocclusion (based on ANB angle) Written informed parental consent Exclusion Criteria: Presence of systemic diseases Current use of medications such as anticonvulsants, immunosuppressants, or calcium channel blockers Exposure to stressful life events within the past month Presence of deleterious oral habits (e.g., thumb sucking, mouth breathing, infantile swallowing) Signs of tonsillar hypertrophy, nasal deviation, nasal polyps, or adenoid vegetation Diagnosis of sleep-disordered breathing (SDB) History of orofacial surgery or orthodontic treatment Presence of craniofacial anomalies (e.g., cleft lip/palate, syndromes)

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

Sleep Quality (CSHQ Score)

Timeframe: At baseline (single assessment)

Trial details

NCT IDNCT07161401

SponsorSerap Titiz Yurdakal

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2023-06-01

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