Sleep QualityNCT07161401
Sagittal Malocclusion and Sleep Quality in Children
An observational study of Sleep Quality, run by Serap Titiz Yurdakal at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 13 daysHealthy volunteers can take part
- Conditions the study is for
- Sleep Quality
- What is being tested?
- Observational assessment
- How many people
- 164 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 1 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 13 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study population consisted of children aged 7-13 years presenting with skeletal Class I, II, or III malocclusion. Only patients without systemic diseases, orofacial functional disorders, previous orthodontic treatment, or craniofacial anomalies were included
Who may be able to join
- Children aged 7-13 years
- Presence of skeletal Class I, II, or III malocclusion (based on ANB angle)
- Written informed parental consent
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uşak University, Faculty of Dentistry, Department of Orthodontics
Uşak
About this study
Official title: Sagittal Skeletal Malocclusions and Sleep Quality in Children Without Orofacial Dysfunction
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.
Read the detailed description
This observational cross-sectional study investigated the potential impact of sagittal skeletal malocclusions on sleep quality in children without orofacial functional disorders. Sleep and craniofacial growth are closely related, and functional disturbances such as atypical swallowing or thumb-sucking are known to influence both airway patency and sleep. To isolate the independent role of skeletal discrepancies, children with orofacial dysfunction were excluded. A total of 164 children aged 7-13 years were evaluated. Sleep quality was measured using the Children's Sleep Habits Questionnaire (CSHQ). Based on cephalometric analysis, participants were classified into skeletal Class I, II, or III according to the ANB angle. Additional cephalometric parameters, including mandibular position (SNB), vertical skeletal dimensions (SNGoGn and FMA angles), and two-dimensional upper airway dimensions, were recorded. For each skeletal group, comparisons were made regarding demographic data, sleep scores, and craniofacial measurements. Correlations between CSHQ scores and cephalometric values were further analyzed separately in male and female patients. The results showed significant differences in mandibular positioning across skeletal groups, with males in Class II presenting higher vertical values than those in Class I or III. However, no significant differences were found between skeletal groups in terms of sleep quality or airway dimensions, and no correlation was observed between sleep quality scores and skeletal measurements in either sex. In conclusion, the findings suggest that, in the absence of orofacial functional disorders, sagittal skeletal malocclusions alone may not significantly affect pediatric sleep quality. This study highlights the importance of differentiating skeletal anomalies from functional disturbances when investigating the complex relationship between craniofacial development and sleep in children.
- Conditions
- Sleep Quality
- Being tested
- Observational assessment
- Keywords
- Pediatric sleep
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational assessmentOther
Evaluation of sleep quality using the Children's Sleep Habits Questionnaire (CSHQ) and cephalometric analysis of mandibular position (SNB), vertical dimensions (SNGoGn, FMA), and upper airway measurements. No active intervention was performed.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Skeletal Class I | Participants with skeletal Class I malocclusion based on ANB angle. Receives: Other: Observational assessment | |
| Group 2: Skeletal Class II | Participants with skeletal Class II malocclusion based on ANB angle. Receives: Other: Observational assessment | |
| Group 3: Skeletal Class III | Participants with skeletal Class III malocclusion based on ANB angle. Receives: Other: Observational assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep Quality (CSHQ Score)
Sleep quality was assessed using the Children's Sleep Habits Questionnaire (CSHQ), a validated parent-reported tool. Higher total scores indicate poorer sleep quality.
Measured: At baseline (single assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2025
- Study start1 Apr 2021
- Primary completion1 Jun 2023
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep QualityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 164 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serap Titiz Yurdakal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Serap Titiz Yurdakal, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07161401
- Sponsor's protocol ID
- 06-06-11
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data (IPD) will be available from the corresponding author upon reasonable request, after publication of the study results.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sagittal Skeletal Malocclusions and Sleep Quality in Children Without Orofacial Dysfunction
- ClinicalTrials.gov ID
- NCT07161401
- Acronym / sponsor ID
- 06-06-11
- Conditions
- Sleep Quality
- Keywords
- Pediatric sleep
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 164 participants (actual)
- Lead sponsor
- Serap Titiz YurdakalUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 8 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This observational cross-sectional study investigated the potential impact of sagittal skeletal malocclusions on sleep quality in children without orofacial functional disorders. Sleep and craniofacial growth are closely related, and functional disturbances such as atypical swallowing or thumb-sucking are known to influence both airway patency and sleep. To isolate the independent role of skeletal discrepancies, children with orofacial dysfunction were excluded. A total of 164 children aged 7-13 years were evaluated. Sleep quality was measured using the Children's Sleep Habits Questionnaire (CSHQ). Based on cephalometric analysis, participants were classified into skeletal Class I, II, or III according to the ANB angle. Additional cephalometric parameters, including mandibular position (SNB), vertical skeletal dimensions (SNGoGn and FMA angles), and two-dimensional upper airway dimensions, were recorded. For each skeletal group, comparisons were made regarding demographic data, sleep scores, and craniofacial measurements. Correlations between CSHQ scores and cephalometric values were further analyzed separately in male and female patients. The results showed significant differences in mandibular positioning across skeletal groups, with males in Class II presenting higher vertical values than those in Class I or III. However, no significant differences were found between skeletal groups in terms of sleep quality or airway dimensions, and no correlation was observed between sleep quality scores and skeletal measurements in either sex. In conclusion, the findings suggest that, in the absence of orofacial functional disorders, sagittal skeletal malocclusions alone may not significantly affect pediatric sleep quality. This study highlights the importance of differentiating skeletal anomalies from functional disturbances when investigating the complex relationship between craniofacial development and sleep in children.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1: Skeletal Class I | – | Other: Observational assessmentParticipants with skeletal Class I malocclusion based on ANB angle. |
| Group 2: Skeletal Class II | – | Other: Observational assessmentParticipants with skeletal Class II malocclusion based on ANB angle. |
| Group 3: Skeletal Class III | – | Other: Observational assessmentParticipants with skeletal Class III malocclusion based on ANB angle. |
Who may qualify
- Ages
- 7 to 13 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study population consisted of children aged 7-13 years presenting with skeletal Class I, II, or III malocclusion. Only patients without systemic diseases, orofacial functional disorders, previous orthodontic treatment, or craniofacial anomalies were included
Key inclusion criteria (3 listed)
- Children aged 7-13 years
- Presence of skeletal Class I, II, or III malocclusion (based on ANB angle)
- Written informed parental consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational assessmentEvaluation of sleep quality using the Children's Sleep Habits Questionnaire (CSHQ) and cephalometric analysis of mandibular position (SNB), vertical dimensions (SNGoGn, FMA), and upper airway measurements. No active intervention was performed. | Other | Group 1: Skeletal Class I, Group 2: Skeletal Class II, Group 3: Skeletal Class III |
Primary outcome
Sleep Quality (CSHQ Score)
Time frame: At baseline (single assessment)
Sleep quality was assessed using the Children's Sleep Habits Questionnaire (CSHQ), a validated parent-reported tool. Higher total scores indicate poorer sleep quality.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD) will be available from the corresponding author upon reasonable request, after publication of the study results.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Quality, run by Serap Titiz Yurdakal at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep Quality (CSHQ Score) (time frame: At baseline (single assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.