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New treatment option for Sleep Apnea, Obstructive
Official title Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome
ClinicalTrials.gov ID: NCT07446634
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Clinical diagnosis of obstructive sleep apnea with AHI ≥15 events/h.
- Residence and/or registration in Dalarna County
- Body mass index (BMI; kg/m\^2) between 15 and 35
- Documented failure of CPAP or mandibular advancement therapy.
You likely can't join if
- Medical conditions contraindicating general anesthesia.
- American Society of Anesthesiologists Physical Status (ASA) Class III-VI
- Central sleep apnea
- Narcolepsy
- Prior orthognathic surgery
- History of tumor disease or radiotherapy of the jaws. Participants with systemic conditions associated with an increased risk of OSA. Such risks...
See the full eligibility criteria
- Clinical diagnosis of obstructive sleep apnea with AHI ≥15 events/h.
- Residence and/or registration in Dalarna County
- Body mass index (BMI; kg/m\^2) between 15 and 35
- Documented failure of CPAP or mandibular advancement therapy.
- Medical conditions contraindicating general anesthesia.
- American Society of Anesthesiologists Physical Status (ASA) Class III-VI
- Central sleep apnea
- Narcolepsy
- Prior orthognathic surgery
- History of tumor disease or radiotherapy of the jaws. Participants with systemic conditions associated with an increased risk of OSA. Such risks include;
- Hypothyroidism
- Acromegaly
- Diabetes mellitus
- Active generalized rheumatoid arthritis
- Clinically manifest periodic limb movement disorder
- Restless legs syndrome.
The study team makes the final eligibility decision.
Where it's taking place
- Falun, Dalarna County, Sweden
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Falun, Dalarna County, Sweden. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.