OSA - Obstructive Sleep ApneaNCT07734688
Miniscrew-Assisted Rapid Palatal Expansion for Obstructive Sleep Apnea
A study testing Miniscrew-Assisted Rapid Palatal Expansion in people with OSA - Obstructive Sleep Apnea and Palatal Expansion Technique, run by University of Malaya.
Trial summary
The goal of this clinical trial is to learn whether miniscrew-assisted rapid palatal expansion (MARPE) can improve obstructive sleep apnea (OSA) in late adolescents and adults aged 16 to 60 years. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- OSA - Obstructive Sleep Apnea, Palatal Expansion Technique
- What is being tested?
- Miniscrew-Assisted Rapid Palatal Expansion
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 20 Feb 2027
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- AHI ≥ 5
- Aged ≥ 16 and ≤ 60 years old
- Presence of the upper first permanent molars
- Presence of unilateral or bilateral posterior crossbite or maxillary transverse deficiency (considering intermolar width measurements, posterior teeth buccolingual incli- nation, and posterior crossbites) allowing meaningful maxillary expansion of at least 5mm
- Willingness to undergo MARPE treatment under the standard fee structure of the Faculty of Dentistry, Universiti Malaya
Who cannot join
- BMI ≥ 30 kg/m2
- Basic Periodontal Examination (BPE) ≥ 3 or BPE markers* (root bifurcation lesions)
- Mobile teeth (Mobility grade ≥ 1)
- Pathology in the maxilla, such as substantial maxillary bone defects, or maxillary bone defects due to space-occupying cysts, tumors, etc.
- Significant true skeletal asymmetry
- Presence of significant root resorption of upper first permanent molars due to previous orthodontic treatments
Show all 15Show fewer
- Concurrent on-going treatment for OSA such CPAP
- Previous treatment for OSA such as soft tissue or hard tissue surgery within the past 4 months
- Significant mandibular retrognathic (SNB less than normal value cephalometrically)
- General chronic medical illnesses like cardiac failure, kidney failure, stroke etc.
- Medication
- Syndromic
- Presence of neuropsychiatric illnesses such insomnia, narcolepsy, parasomnia etc.
- Presence of neuromuscular diseases such multiple schlerosis, epilepsy, Parkinson's disease.
- -
About this study
Official title: The Effectiveness of Miniscrew-Assisted Rapid Palatal Expansion in the Management of Obstructive Sleep Apnea: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to learn whether miniscrew-assisted rapid palatal expansion (MARPE) can improve obstructive sleep apnea (OSA) in late adolescents and adults aged 16 to 60 years. The main questions it aims to answer are:
- Does MARPE improve sleep apnea severity, as measured by Home Sleep Apnea Testing (HSAT), including respiratory event index (REI), oxygen desaturation index (ODI), mean oxygen saturation, nadir oxygen saturation, snoring events, and body position?
- Does MARPE improve breathing and sleep-related symptoms, including upper airway dimensions, daytime sleepiness, quality of life, and peak nasal inspiratory flow (PNIF)?
Read more
Researchers will compare a MARPE group with a control group that receives standard care for obstructive sleep apnea for 3 months to see whether MARPE provides additional benefit.
Participants will:
- Receive standard care for obstructive sleep apnea
- Be randomly assigned to either MARPE plus standard care or standard care alone for 3 months
- In the MARPE group, wear a miniscrew-assisted rapid palatal expander and activate it according to the study protocol
- Visit the clinic for follow-up care and monitoring
- Data will be collected at baseline (T0) and 3 months (T1). At both time points, participants in the MARPE group will be assessed using Home Sleep Apnea Testing (HSAT), cone beam computed tomography (CBCT), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10), and peak nasal inspiratory flow (PNIF). Participants in the control group will be assessed using HSAT, ESS, FOSQ-10, and PNIF.
Read the detailed description
This is a single-blind, double-arm, parallel-group randomized controlled trial designed to evaluate the effectiveness of miniscrew-assisted rapid palatal expansion (MARPE) in late adolescents and adults with obstructive sleep apnea (OSA). A total of 24 participants aged 16 to 60 years will be enrolled if they meet the study criteria. Eligible participants must have OSA, as shown by an apnea-hypopnea index (AHI) of 5 or higher, and must also have maxillary transverse deficiency, such as posterior crossbite or reduced maxillary intermolar width. Participants with severe obesity, active periodontal problems, mobile teeth, major maxillary pathology, previous orthodontic treatment, or recent OSA treatment will not be included.
Participants will be assigned by gender-stratified block randomization in a 1:1 ratio to either the test group or the control group. The test group will receive MARPE with standard care for OSA. The control group will receive standard care for OSA for 3 months and will be offered MARPE after the 3-month assessment if they wish to undergo treatment.
The MARPE device used in this study is the Maxillary Skeletal Expander II. Expansion will begin according to the manufacturer's instructions until a median diastema appears, and then the screw will be activated two turns per day until overcorrection is reached. After expansion, the appliance will remain in place for 6 months as retention to allow bone formation.
Data will be collected at baseline before the start of treatment (T0) and three months after the completion of expansion (T1). At both T0 and T1 the test group will undergo assessment using Home Sleep Apnea Testing (HSAT), cone beam computed tomography (CBCT), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10), and peak nasal inspiratory flow (PNIF); the control group will undergo assessment using HSAT, ESS, FOSQ-10 and PNIF.
- Being tested
- Miniscrew-Assisted Rapid Palatal Expansion, Standard Care (in control arm)
- Keywords
- obstructive sleep apnea, miniscrew-assisted rapid palatal expansion, MARPE, adult, palatal expansion technique
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miniscrew-Assisted Rapid Palatal ExpansionDevice
Also called MARPE, palatal expansion technique, maxillary skeletal expansion, Maxillary skeletal expander
This intervention uses a standardized miniscrew-assisted rapid palatal expansion (MARPE) protocol to achieve maxillary expansion in skeletally mature patients with obstructive sleep apnea. Unlike conventional tooth-borne rapid maxillary expansion (RME), MARPE is designed to achieve more skeletal expansion and reduce unwanted dental effects. Compared with surgically assisted expansion techniques such as SARPE and DOME, this intervention is non-surgical and focuses on correcting transverse maxillary deficiency as a contributing anatomical factor in upper airway narrowing.
Standard Care (in control arm)Other
This control group is a 3-month wait-list standard care arm for obstructive sleep apnea (OSA). During the trial period, participants will receive conservative and physician-directed management only, including lifestyle advice (e.g., weight management, sleep hygiene, positional therapy, and avoidance of alcohol or sedatives before sleep), medical management if indicated, and treatment of nasal obstruction as appropriate (e.g., topical nasal steroids or antihistamines). Participants will be monitored every 4 weeks and may receive rescue CPAP if clinically indicated. Unlike the experimental arm, no active maxillary expansion will be provided during the waiting period; MARPE will be offered after the 3-month assessment if they wish to undergo treatment.
| Study group | Role | What they receive |
|---|---|---|
| MARPE | Experimental | Participants in the test group will receive standard care for obstructive sleep apnea (OSA), including lifestyle and conservative measures, medical management if indicated, and treatment of nasal obstruction as appropriate.
In addition, participants will undergo maxillary skeletal expansion using a Mini-screw Assisted Rapid Palatal Expansion (MARPE) device (Maxillary Skeletal Expander II, MSE; Biomaterials Korea, Seoul, South Korea). The device will be custom-fabricated and anchored with mini-screws under local anaesthesia.
Expansion will follow manufacturer instructions and continue with two turns per day until overcorrection is achieved. The device will then be retained in situ for approximately six months without further activation.
Participants will be reviewed one week after placement and then 1-4 times per month depending on clinical need. During follow-up visits, pain, discomfort, oral hygiene, and compliance will be monitored. Receives: Device: Miniscrew-Assisted Rapid Palatal Expansion |
| Wait-list Control | Other | This control group is a 3-month wait-list standard care arm for obstructive sleep apnea (OSA). During the trial period, participants will receive conservative and physician-directed management only, including lifestyle advice (e.g., weight management, sleep hygiene, positional therapy, and avoidance of alcohol or sedatives before sleep), medical management if indicated, and treatment of nasal obstruction as appropriate (e.g., topical nasal steroids or antihistamines). Participants will be monitored every 4 weeks and may receive rescue CPAP if clinically indicated. Unlike the experimental arm, no active maxillary expansion will be provided during the waiting period; MARPE will be offered after the 3-month assessment if they wish to undergo treatment. Receives: Other: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea Hyponea Index(AHI)
Measured: "From treatment begin/recruited to the end of treatment/recruited at 3 months"
Secondary outcomes (4)
Cone Beam Computed Tomography
Measured: "From treatment begin/ recruited to the end of treatment/recruited at 3 months"
Epworth Sleepiness Scale
Measured: "From treatment begin/ recruited to the end of treatment/recruited at 3 months"
Functional Outcomes of Sleep Questionnaire Short Version
Measured: "From treatment begin/ recruited to the end of treatment/recruited at 3 months"
Peak Nasal Inspiratory Flow
Measured: "From treatment begin/recruited to the end of treatment/recruited at 3 months"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion20 Feb 2027 (estimated)
- Study completion20 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSA - Obstructive Sleep ApneaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI QIANYU, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07734688
- Sponsor's protocol ID
- DF CD2605/0015 (P)
- Status last verified
- Jul 2026
- First submitted
- 20 Jul 2026
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Miniscrew-Assisted Rapid Palatal Expansion in the Management of Obstructive Sleep Apnea: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07734688
- Acronym / sponsor ID
- DF CD2605/0015 (P)
- Keywords
- obstructive sleep apnea, miniscrew-assisted rapid palatal expansion, MARPE, adult, palatal expansion technique
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 20 Feb 2027 (estimated)
- Study completion
- 20 Feb 2027 (estimated)
- First posted
- 29 Jul 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.
The goal of this clinical trial is to learn whether miniscrew-assisted rapid palatal expansion (MARPE) can improve obstructive sleep apnea (OSA) in late adolescents and adults aged 16 to 60 years. The main questions it aims to answer are:
- Does MARPE improve sleep apnea severity, as measured by Home Sleep Apnea Testing (HSAT), including respiratory event index (REI), oxygen desaturation index (ODI), mean oxygen saturation, nadir oxygen saturation, snoring events, and body position?
- Does MARPE improve breathing and sleep-related symptoms, including upper airway dimensions, daytime sleepiness, quality of life, and peak nasal inspiratory flow (PNIF)?
Researchers will compare a MARPE group with a control group that receives standard care for obstructive sleep apnea for 3 months to see whether MARPE provides additional benefit.
Participants will:
- Receive standard care for obstructive sleep apnea
- Be randomly assigned to either MARPE plus standard care or standard care alone for 3 months
- In the MARPE group, wear a miniscrew-assisted rapid palatal expander and activate it according to the study protocol
- Visit the clinic for follow-up care and monitoring
- Data will be collected at baseline (T0) and 3 months (T1). At both time points, participants in the MARPE group will be assessed using Home Sleep Apnea Testing (HSAT), cone beam computed tomography (CBCT), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10), and peak nasal inspiratory flow (PNIF). Participants in the control group will be assessed using HSAT, ESS, FOSQ-10, and PNIF.
Detailed description
This is a single-blind, double-arm, parallel-group randomized controlled trial designed to evaluate the effectiveness of miniscrew-assisted rapid palatal expansion (MARPE) in late adolescents and adults with obstructive sleep apnea (OSA). A total of 24 participants aged 16 to 60 years will be enrolled if they meet the study criteria. Eligible participants must have OSA, as shown by an apnea-hypopnea index (AHI) of 5 or higher, and must also have maxillary transverse deficiency, such as posterior crossbite or reduced maxillary intermolar width. Participants with severe obesity, active periodontal problems, mobile teeth, major maxillary pathology, previous orthodontic treatment, or recent OSA treatment will not be included.
Participants will be assigned by gender-stratified block randomization in a 1:1 ratio to either the test group or the control group. The test group will receive MARPE with standard care for OSA. The control group will receive standard care for OSA for 3 months and will be offered MARPE after the 3-month assessment if they wish to undergo treatment.
The MARPE device used in this study is the Maxillary Skeletal Expander II. Expansion will begin according to the manufacturer's instructions until a median diastema appears, and then the screw will be activated two turns per day until overcorrection is reached. After expansion, the appliance will remain in place for 6 months as retention to allow bone formation.
Data will be collected at baseline before the start of treatment (T0) and three months after the completion of expansion (T1). At both T0 and T1 the test group will undergo assessment using Home Sleep Apnea Testing (HSAT), cone beam computed tomography (CBCT), Epworth Sleepiness Scale (ESS), Functional Outcomes of Sleep Questionnaire Short Version (FOSQ-10), and peak nasal inspiratory flow (PNIF); the control group will undergo assessment using HSAT, ESS, FOSQ-10 and PNIF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MARPE | Experimental | Device: Miniscrew-Assisted Rapid Palatal ExpansionParticipants in the test group will receive standard care for obstructive sleep apnea (OSA), including lifestyle and conservative measures, medical management if indicated, and treatment of nasal obstruction as appropriate. In addition, participants will undergo maxillary skeletal expansion using a Mini-screw Assisted Rapid Palatal Expansion (MARPE) device (Maxillary Skeletal Expander II, MSE; Biomaterials Korea, Seoul, South Korea). The device will be custom-fabricated and anchored with mini-screws under local anaesthesia. Expansion will follow manufacturer instructions and continue with two turns per day until overcorrection is achieved. The device will then be retained in situ for approximately six months without further activation. Participants will be reviewed one week after placement and then 1-4 times per month depending on clinical need. During follow-up visits, pain, discomfort, oral hygiene, and compliance will be monitored. |
| Wait-list Control | Other | Other: Standard Care (in control arm)This control group is a 3-month wait-list standard care arm for obstructive sleep apnea (OSA). During the trial period, participants will receive conservative and physician-directed management only, including lifestyle advice (e.g., weight management, sleep hygiene, positional therapy, and avoidance of alcohol or sedatives before sleep), medical management if indicated, and treatment of nasal obstruction as appropriate (e.g., topical nasal steroids or antihistamines). Participants will be monitored every 4 weeks and may receive rescue CPAP if clinically indicated. Unlike the experimental arm, no active maxillary expansion will be provided during the waiting period; MARPE will be offered after the 3-month assessment if they wish to undergo treatment. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- AHI ≥ 5
- Aged ≥ 16 and ≤ 60 years old
- Presence of the upper first permanent molars
- Presence of unilateral or bilateral posterior crossbite or maxillary transverse deficiency (considering intermolar width measurements, posterior teeth buccolingual incli- nation, and posterior crossbites) allowing meaningful maxillary expansion of at least 5mm
- Willingness to undergo MARPE treatment under the standard fee structure of the Faculty of Dentistry, Universiti Malaya
Key exclusion criteria (15 listed)
- BMI ≥ 30 kg/m2
- Basic Periodontal Examination (BPE) ≥ 3 or BPE markers* (root bifurcation lesions)
- Mobile teeth (Mobility grade ≥ 1)
- Pathology in the maxilla, such as substantial maxillary bone defects, or maxillary bone defects due to space-occupying cysts, tumors, etc.
- Significant true skeletal asymmetry
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 |
|---|---|---|
| Miniscrew-Assisted Rapid Palatal ExpansionAlso: MARPE, palatal expansion technique, maxillary skeletal expansion, Maxillary skeletal expanderThis intervention uses a standardized miniscrew-assisted rapid palatal expansion (MARPE) protocol to achieve maxillary expansion in skeletally mature patients with obstructive sleep apnea. Unlike conventional tooth-borne rapid maxillary expansion (RME), MARPE is designed to achieve more skeletal expansion and reduce unwanted dental effects. Compared with surgically assisted expansion techniques such as SARPE and DOME, this intervention is non-surgical and focuses on correcting transverse maxillary deficiency as a contributing anatomical factor in upper airway narrowing. | Device | MARPE |
| Standard Care (in control arm)This control group is a 3-month wait-list standard care arm for obstructive sleep apnea (OSA). During the trial period, participants will receive conservative and physician-directed management only, including lifestyle advice (e.g., weight management, sleep hygiene, positional therapy, and avoidance of alcohol or sedatives before sleep), medical management if indicated, and treatment of nasal obstruction as appropriate (e.g., topical nasal steroids or antihistamines). Participants will be monitored every 4 weeks and may receive rescue CPAP if clinically indicated. Unlike the experimental arm, no active maxillary expansion will be provided during the waiting period; MARPE will be offered after the 3-month assessment if they wish to undergo treatment. | Other | Wait-list Control |
Primary outcome
Apnea Hyponea Index(AHI)
Time frame: "From treatment begin/recruited to the end of treatment/recruited at 3 months"
4 secondary outcomes
Cone Beam Computed Tomography
Time frame: "From treatment begin/ recruited to the end of treatment/recruited at 3 months"
Epworth Sleepiness Scale
Time frame: "From treatment begin/ recruited to the end of treatment/recruited at 3 months"
Functional Outcomes of Sleep Questionnaire Short Version
Time frame: "From treatment begin/ recruited to the end of treatment/recruited at 3 months"
Peak Nasal Inspiratory Flow
Time frame: "From treatment begin/recruited to the end of treatment/recruited at 3 months"
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 29 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Miniscrew-Assisted Rapid Palatal Expansion in people with OSA - Obstructive Sleep Apnea and Palatal Expansion Technique, run by University of Malaya.
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 5 inclusion and 15 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: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Apnea Hyponea Index(AHI) (time frame: "From treatment begin/recruited to the end of treatment/recruited at 3 months"). 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 29 Jul 2026.