Obstructive Sleep Apnea of AdultOBMADNCT06256640
Mandibular Advancement Device (MAD) in Pregnant Women With Obstructive Sleep Apnea (OSA)
A study testing Mandibular advancement Device in people with Obstructive Sleep Apnea of Adult and Pregnancy Related, run by Henry Ford Health System at 1 site in United States.
Trial summary
We propose a single-arm trial to test the patient uptake and preliminary efficacy of MAD in a sample of 10 pregnant women with mild-to-moderate OSA. Study outcomes include patient-reported symptoms and objectively assessed sleep parameters assessed before treatment, during and after 10 weeks of MAD intervention… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea of Adult, Pregnancy Related
- What is being tested?
- Mandibular advancement Device
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Feb 2025
- Phase
- Interventional
- 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy, gestational week 14-20.
- Age ≥ 18, English-speaking.
- Reliable internet access (questionnaires/surveys)
- Untreated mild to mild-moderate OSA defined as AHI between 5-20 events/hour on the most recent home sleep study
- No significant hypoxemia on the initial sleep study defined as SaO2 nadir ≥70% and SaO2 equal or less than 30 minutes ≥88%
- The sleep study must have been a home sleep test that uses Peripheral Arterial Tone signal for evaluation of apneic events. The home sleep test has to be a WatchPAT device (WatchPAT® Home Sleep Study Device | Itamar Medical Ltd.).
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- No significant confounding comorbidities including restless leg symptoms and circadian disorders (shift work)
- BMI less or equal to 40 and neck size less or equal to 40 cm
- Good oral health with manual dexterity and at least 8 tooth per arch
Who cannot join
- High risk pregnancy (age >40y, superimposed preeclampsia, pre-existing cardiac disease, severe organ dysfunction such as liver or renal failure, any condition that requires anticoagulation), and any condition Dr. Pitts or Dr Smith deem serious risk to mother/fetus. Well controlled chronic hypertension and diabetes are allowed and will not be excluded.
- Dental exclusion criteria: Complete edentulous arch, ongoing oral rehabilitation, uncontrolled periodontal disease, ongoing orthodontic treatment or completed treatment in a period less than 5 years, temporomandibular dysfunction (active acute pain or limitations on mandibula movements of any kind), prior oropharyngeal surgery, maximum protrusion less 5 mm
- Significant acute health problems that are unrelated to pregnancy or dental diseases including unstable psychiatric disease
- Non-English speaking
- Unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mandibular Advancement Device (MAD) as an Alternative Treatment Option in Pregnant Women With Obstructive Sleep Apnea (OSA)
We propose a single-arm trial to test the patient uptake and preliminary efficacy of MAD in a sample of 10 pregnant women with mild-to-moderate OSA. Study outcomes include patient-reported symptoms and objectively assessed sleep parameters assessed before treatment, during and after 10 weeks of MAD intervention (during pregnancy) and postpartum.
Read the detailed description
The purpose of this study is to explore MAD as an alternative treatment option for OSA in pregnant women. We are recruiting a small number of 10 healthy pregnant women with uncomplicated OSA (absence of significant cardiovascular, metabolic or neurocognitive consequences) who, after being offered CPAP as the recommended standard treatment, prefer to use a MAD over CPAP. All patients are recruited from a single center. We would like to get a first impression on the comfort level of these women with the MAD and their self-reported compliance and any improvement of symptoms with treatment. Additionally, we would like to test efficacy in controlling OSA with pregnancy progression. Finally, we would like to derive overall treatment effectiveness of the MAD in pregnant women as defined as a combination of efficacy and compliance.
- Being tested
- Mandibular advancement Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mandibular advancement DeviceDevice
Intra oral appliances and more specifically Mandibular Advance Devices (MAD) are one of the established alternatives to treat OSA. Oral appliances and MAD are often used interchangeably but we prefer to call them MAD as it is more descriptive of its mechanism of action. MAD are placed in the mouth to temporarily advance and stabilize the lower jaw forward in order to keep the airway open during sleep.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: Mandibular advancement Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe patient uptake of MAD
MAD adherence will be determined via patient-reported sleep diaries during the first 10-weeks of MAD intervention according to the AADSM guidelines. Specifically, patients will report each morning whether they wore their MAD and to estimate how long they wore it for. Consistent with Medicare guidelines for PAP therapy, we will operationalize compliance as wearing the device for ≥4 hrs each night for 70% of nights. We will describe compliance rates.
Measured: 9 months
Evaluate preliminary efficacy of MAD for treating mild-to-moderate OSA
We will assess AHI before treatment (T1), after 10 weeks of MAD treatment during pregnancy (T2), and then finally three months after childbirth (T3) via home sleep tests used in our sleep clinic per standard care. We hypothesize that AHI at T2 and T3 will be significantly lower than T1. For descriptive purposes, we will report rates of OSA remission (AHI<5) at T2 and T3 as well as rates of positive treatment response operationalized as a ≥50% reduction in AHI from T1.
Measured: 9 months
Test for changes in patient-reported symptoms.
OSA is associated with increased fatigue and sleepiness. We hypothesize that patients will report lower levels of fatigue and daytime sleepiness at T2 and T3 relative to T1 baseline.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start1 Feb 2024
- Primary completion1 Feb 2025 (estimated)
- Study completion1 Feb 2025 (estimated)
Why it stopped: unable to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obstructive Sleep Apnea of AdultStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot clinical trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Miriam Jaziri, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256640
- Sponsor's protocol ID
- 15984-01
- Acronym
- OBMAD
- Status last verified
- Jan 2025
- First submitted
- 5 Feb 2024
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mandibular Advancement Device (MAD) as an Alternative Treatment Option in Pregnant Women With Obstructive Sleep Apnea (OSA)
- ClinicalTrials.gov ID
- NCT06256640
- Acronym / sponsor ID
- OBMAD / 15984-01
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: unable to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2025 (estimated)
- Study completion
- 1 Feb 2025 (estimated)
- First posted
- 13 Feb 2024 (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.
We propose a single-arm trial to test the patient uptake and preliminary efficacy of MAD in a sample of 10 pregnant women with mild-to-moderate OSA. Study outcomes include patient-reported symptoms and objectively assessed sleep parameters assessed before treatment, during and after 10 weeks of MAD intervention (during pregnancy) and postpartum.
Detailed description
The purpose of this study is to explore MAD as an alternative treatment option for OSA in pregnant women. We are recruiting a small number of 10 healthy pregnant women with uncomplicated OSA (absence of significant cardiovascular, metabolic or neurocognitive consequences) who, after being offered CPAP as the recommended standard treatment, prefer to use a MAD over CPAP. All patients are recruited from a single center. We would like to get a first impression on the comfort level of these women with the MAD and their self-reported compliance and any improvement of symptoms with treatment. Additionally, we would like to test efficacy in controlling OSA with pregnancy progression. Finally, we would like to derive overall treatment effectiveness of the MAD in pregnant women as defined as a combination of efficacy and compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot clinical trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Mandibular advancement Device |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Singleton pregnancy, gestational week 14-20.
- Age ≥ 18, English-speaking.
- Reliable internet access (questionnaires/surveys)
- Untreated mild to mild-moderate OSA defined as AHI between 5-20 events/hour on the most recent home sleep study
- No significant hypoxemia on the initial sleep study defined as SaO2 nadir ≥70% and SaO2 equal or less than 30 minutes ≥88%
Key exclusion criteria (5 listed)
- High risk pregnancy (age >40y, superimposed preeclampsia, pre-existing cardiac disease, severe organ dysfunction such as liver or renal failure, any condition that requires anticoagulation), and any condition Dr. Pitts or Dr Smith deem serious risk to mother/fetus. Well controlled chronic hypertension and diabetes are allowed and will not be excluded.
- Dental exclusion criteria: Complete edentulous arch, ongoing oral rehabilitation, uncontrolled periodontal disease, ongoing orthodontic treatment or completed treatment in a period less than 5 years, temporomandibular dysfunction (active acute pain or limitations on mandibula movements of any kind), prior oropharyngeal surgery, maximum protrusion less 5 mm
- Significant acute health problems that are unrelated to pregnancy or dental diseases including unstable psychiatric disease
- Non-English speaking
- Unable to provide informed consent
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 |
|---|---|---|
| Mandibular advancement DeviceIntra oral appliances and more specifically Mandibular Advance Devices (MAD) are one of the established alternatives to treat OSA. Oral appliances and MAD are often used interchangeably but we prefer to call them MAD as it is more descriptive of its mechanism of action. MAD are placed in the mouth to temporarily advance and stabilize the lower jaw forward in order to keep the airway open during sleep. | Device | Intervention |
Primary outcome
Describe patient uptake of MAD
Time frame: 9 months
MAD adherence will be determined via patient-reported sleep diaries during the first 10-weeks of MAD intervention according to the AADSM guidelines. Specifically, patients will report each morning whether they wore their MAD and to estimate how long they wore it for. Consistent with Medicare guidelines for PAP therapy, we will operationalize compliance as wearing the device for ≥4 hrs each night for 70% of nights. We will describe compliance rates.
Evaluate preliminary efficacy of MAD for treating mild-to-moderate OSA
Time frame: 9 months
We will assess AHI before treatment (T1), after 10 weeks of MAD treatment during pregnancy (T2), and then finally three months after childbirth (T3) via home sleep tests used in our sleep clinic per standard care. We hypothesize that AHI at T2 and T3 will be significantly lower than T1. For descriptive purposes, we will report rates of OSA remission (AHI<5) at T2 and T3 as well as rates of positive treatment response operationalized as a ≥50% reduction in AHI from T1.
Test for changes in patient-reported symptoms.
Time frame: 9 months
OSA is associated with increased fatigue and sleepiness. We hypothesize that patients will report lower levels of fatigue and daytime sleepiness at T2 and T3 relative to T1 baseline.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2025.
- Individual participant dataSharing planned: Undecided
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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.
Miriam Jaziri, MD principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mandibular advancement Device in people with Obstructive Sleep Apnea of Adult and Pregnancy Related, run by Henry Ford Health System at 1 site in United States.
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 9 inclusion and 5 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: withdrawn, as of the sponsor's last update on 29 Jan 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 United States. 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 was withdrawn before enrolling participants, so there are no results.
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?
Describe patient uptake of MAD (time frame: 9 months). The study lists 3 primary outcomes in all. 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 Jan 2025.