Health TrialsbyHealthPanel

Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome

ConditionSleep Apnea, Obstructive
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorJani Talvilahti

About this trial

This study looks at how jaw surgery called maxillomandibular advancement with counterclockwise rotation affects breathing during sleep in people with moderate to severe obstructive sleep apnea who cannot tolerate standard treatments such as Continous Positive Airway pressure treatment. The participants are followed over time to see whether the surgery improves sleep apnea symptoms, daytime sleepiness, and airway size, and whether these improvements last. Advanced three-dimensional imaging and airflow analysis are used to better understand how the surgery changes the airway and breathing. The goal is to evaluate the long-term effectiveness and safety of this surgical treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Clinical diagnosis of obstructive sleep apnea with AHI ≥15 events/h.

Residence and/or registration in Dalarna County

Body mass index (BMI; kg/m²) between 15 and 35

Documented failure of CPAP or mandibular advancement therapy.

Disqualifiers

Medical conditions contraindicating general anesthesia.

American Society of Anesthesiologists Physical Status (ASA) Class III-VI

Central sleep apnea

Narcolepsy

Trial design

Design model

Single group

Treatments tested in this trial

  • Maxillomandibular advancement surgery with counterclockwise rotation

    Procedure/Surgery

    Maxillary advancement by LeFort I osteotomy and mandibular advancement by bilateral sagittal split osteotomy

Treatment groups

48 Participants
are divided into 1 treatment group
Group A: InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Apnea Hypopnea Index (AHI/h)

Change in AHI/h. Lower value means better outcome, value \< 5 is considered healthy.

Time frame
Registration presurgically and at 3 months, 2 years and 5 years post operatively

Secondary outcomes

1

Upper airway volume

Changes in upper airway volume measured in mm\^3.

Time frame
Registration presurgically and at 3 months, 2 years and 5 years post operatively
2

Airway velocity

Changes in airway velocity measured in m/s

Time frame
Registration presurgically and at 3 months, 2 years and at 5 years post operatively.
3

Epworth Sleepiness Scale (ESS)

Assessment of daytime sleepiness using Epworth Sleepiness Scale before and after treatment. Minimum score 0, maximum 24. Higher scores mean a worse outcome,

Time frame
Registration presurgically and at 3 months, 2 years and 5 years post operatively
4

Blood pressure

Assessment of the effect of surgery on both systolic and diastolic blood pressure and blood pressure medication, mmHg.

Time frame
Registration presurgically and at 3 months, 2 years and 5 years post operatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jani Talvilahti

Lead sponsor

Dalarna County Council, Sweden

Sponsor institution

Source ClinicalTrials.gov
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