Sleep Apnea, ObstructiveOSASNCT07446634
Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome
A study testing Maxillomandibular advancement surgery with counterclockwise rotation in people with Sleep Apnea, Obstructive, run by Jani Talvilahti at 1 site in Sweden.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sleep Apnea, Obstructive
- What is being tested?
- Maxillomandibular advancement surgery with counterclockwise rotation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSweden
- Study dates
- 6 Feb 2014to 30 Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- Hypothyroidism
- Acromegaly
- Diabetes mellitus
- Active generalized rheumatoid arthritis
- Clinically manifest periodic limb movement disorder
- Restless legs syndrome.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Falu Hospital
Falun, Dalarna County, 79182
Jani MA Talvilahti, DDS, Head, +46 49 21 08, jani.talvilahti@regiondalarna.se
About this study
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.
- Conditions
- Sleep Apnea, Obstructive
- Being tested
- Maxillomandibular advancement surgery with counterclockwise rotation
- Keywords
- Sleep Apnea, Orthognathic Surgical Procedure, Tomography, Computational Fluid Dynamics
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maxillomandibular advancement surgery with counterclockwise rotationProcedure or surgery
Maxillary advancement by LeFort I osteotomy and mandibular advancement by bilateral sagittal split osteotomy
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Single arm study with counterclockwise rotational maxillo-mandibular advancement surgery Receives: Procedure: Maxillomandibular advancement surgery with counterclockwise rotation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hypopnea Index (AHI/h)
Change in AHI/h. Lower value means better outcome, value < 5 is considered healthy.
Measured: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Secondary outcomes (7)
Upper airway volume
Changes in upper airway volume measured in mm^3.
Measured: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Airway velocity
Changes in airway velocity measured in m/s
Measured: Registration presurgically and at 3 months, 2 years and at 5 years post operatively.
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,
Measured: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Blood pressure
Assessment of the effect of surgery on both systolic and diastolic blood pressure and blood pressure medication, mmHg.
Measured: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Short Form-36 Health Survey
Evaluation of participants Quality of Life through validated questionnaire 36-Item Short Form Health Survey (SF-36). SF-36 is a self-reported questionnaire designed to measure generic health-related quality of life across eight domains, such as physical functioning, bodily pain, and mental health. Higher score means worse outcome.
Measured: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Oral Health Impact Profile - Swedish version
Evaluation of participants Quality of Life through validated questionnaire Oral Health Impact Profile-49 - Swedish version (OHIP-S). It is a comprehensive instrument designed to measure oral health-related quality of life (OHRQoL) across seven dimensions: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Higher score means worse outcome.
Measured: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Jaw Function Limitation Scale.
Evaluation of participants Quality of Life through validated questionnaire Jaw Functional Limitation Scale (JFLS). JFLS is a patient-reported instrument used to assess functional status and limitations of the masticatory system (the jaw), typically in individuals with temporomandibular disorders. Higher score means worse outcome.
Measured: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start6 Feb 2014
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sleep Apnea, ObstructiveStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective singel center study
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jani Talvilahti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jani Talvilahti, Dalarna County Council, Sweden
- Investigators
- Andreas Thor, Professor, Study chair, Department of Surgical Sciences, Oral and Maxillofacial Surgery, Uppsala University, Uppsala, Sweden.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446634
- Sponsor's protocol ID
- 2013/125
- Acronym
- OSAS
- Status last verified
- Feb 2026
- First submitted
- 11 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillomandibular Advancement Surgery for Treatment of Obstructive Sleep Apnoea Syndrome
- ClinicalTrials.gov ID
- NCT07446634
- Acronym / sponsor ID
- OSAS / 2013/125
- Conditions
- Sleep Apnea, Obstructive
- Keywords
- Sleep Apnea, Orthognathic Surgical Procedure, Tomography, Computational Fluid Dynamics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jani TalvilahtiUniversity, hospital or other
- Study start
- 6 Feb 2014 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 3 Mar 2026 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective singel center study
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Procedure: Maxillomandibular advancement surgery with counterclockwise rotationSingle arm study with counterclockwise rotational maxillo-mandibular advancement surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Medical conditions contraindicating general anesthesia.
- American Society of Anesthesiologists Physical Status (ASA) Class III-VI
- Central sleep apnea
- Narcolepsy
- Prior orthognathic surgery
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 |
|---|---|---|
| Maxillomandibular advancement surgery with counterclockwise rotationMaxillary advancement by LeFort I osteotomy and mandibular advancement by bilateral sagittal split osteotomy | Procedure or surgery | Intervention |
Primary outcome
Apnea Hypopnea Index (AHI/h)
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Change in AHI/h. Lower value means better outcome, value < 5 is considered healthy.
7 secondary outcomes
Upper airway volume
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Airway velocity
Time frame: Registration presurgically and at 3 months, 2 years and at 5 years post operatively.
Epworth Sleepiness Scale (ESS)
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Blood pressure
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Short Form-36 Health Survey
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Oral Health Impact Profile - Swedish version
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Quality of Life (QoL), Jaw Function Limitation Scale.
Time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Sleep Apnea, Obstructive
RecruitingObservational study
Development and Validation of a Multimodal Deep Learning Model Using Peripheral Oxygen Saturation and Ballistocardiography Signals for Predicting Apnea-Hypopnea Index in Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 3
A Study to Learn About the Monthly Dosing Study Medicine Called Berobenatide in Adults With Breathing Problems During Sleep and Overweight or Obesity Who Do Not Use a Breathing Machine (PAP) (VESPER-OSA 2)
Apnea, Sleep Disorders
Not yet recruitingPhase 2
Supplemental Oxygen for Sleep-Disordered Breathing in Adults With Chronic Opioid Use.
Sleep-disordered Breathing, Chronic Opioid Use
Recruiting
Nightly Wearable Monitoring During Home-Based Submental Electrical Stimulation for Obstructive Sleep Apnea
Obstructive Sleep Apnea
RecruitingPhase 1/2
DRonabinol Treatment of OSA
Obstructive Sleep Apnea
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.
Andreas Thor, Professor study chair
Department of Surgical Sciences, Oral and Maxillofacial Surgery, Uppsala University, Uppsala, Sweden.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maxillomandibular advancement surgery with counterclockwise rotation in people with Sleep Apnea, Obstructive, run by Jani Talvilahti at 1 site in Sweden.
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 4 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 3 Mar 2026. 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 Sweden. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jani M A Talvilahti, DDS, Head (+46 23 49 21 08, jani.talvilahti@regiondalarna.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea Hypopnea Index (AHI/h) (time frame: Registration presurgically and at 3 months, 2 years and 5 years post operatively). 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 3 Mar 2026.