SnoringPREGNCCTNCT03646214
Improving Sleep Quality During Pregnancy Using an Oral Appliance
A study testing Midline traction oral appliance in people with Snoring and Sleep Fragmentation, run by Texas A&M University at 1 site in United States.
Trial summary
Many pregnant women suffer from poor sleep quality and snoring. Evidence shows an increasing association between (1) sleep disordered breathing and (2) maternal cardiovascular disease and in-hospital death. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Snoring, Sleep Fragmentation
- What is being tested?
- Midline traction oral appliance
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 30 Jul 2026
- 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Pregnant adults who snore
- At least 8 teeth per arch
- Mallampati score from I to II
- Palatine tonsils grade 0,1 or 2
- Capable of giving verbal and written informed consent
- Able to apply the sleep recorder and the oral appliance.
Who cannot join
- Pregnant > 32 weeks
- Uncontrolled serious health issues
- Cardiovascular or cardiac rhythm disorders
- Pharmacological dependency
- Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol
- Ongoing temporomandibular joint disorders
- Loose teeth or periodontal disease
- History of uvulopalatopharyngoplasty (UPPP)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Texas A&M University College of Dentistry
Dallas, Texas, 75246
Zohre German, MS, 214-828-8291, german@tamu.edu
Jason Hui, DDS
About this study
Official title: Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial
Many pregnant women suffer from poor sleep quality and snoring. Evidence shows an increasing association between (1) sleep disordered breathing and (2) maternal cardiovascular disease and in-hospital death. Snoring is a variant of obstructive sleep apnea (OSA) and OSA during pregnancy is associated with higher risks for cesarean delivery, gestational hypertension, preeclampsia and preterm delivery. It may also impact fetal outcomes negatively. The purpose of this study is to determine whether sleep quality can be improved in pregnant women who snore by means of an oral appliance that opens the airway. Sleep quality is evaluated objectively using an un-intrusive home sleep test system.
Read the detailed description
As many as 20 percent of women suffer from snoring and poor sleep quality while pregnant. The purpose of this study is to determine whether sleep can be improved in pregnant women who snore by means of a midline traction oral appliance (OA) that opens the airway. This is an interventional study to objectively evaluate OA therapy on breathing during sleep as well as its effect on sleep quality. Pregnant women from all trimesters will be recruited. Each subject is expected to participate in the study for at least five (5) consecutive weeks. Home sleep recordings will be collected at three time points: T0 - Baseline prior to OA use for two consecutive nights; T1- first two consecutive nights wearing the OA; T2 - for two consecutive nights after 4 weeks of appliance use. In addition to the sleep studies performed at each of these time points, subjects will also complete several brief surveys. All participants will be given the opportunity to use their OAs after the 4 week period, and have their sleep recorded at 8 week intervals through the remainder of their pregnancies. Participants will get to keep and use their OAs after the study.
Pregnant women who snore (or otherwise have poor sleep), may qualify to participate in this study. Those who do not want to wear an oral appliance, but are interested in learning about sleep quality while pregnant, may also qualify to participate as a control subject.
- Conditions
- Snoring, Sleep Fragmentation
- Being tested
- Midline traction oral appliance
- Medical subject headings
- Snoring, Sleep Deprivation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midline traction oral applianceDevice
Also called MyTAP oral appliance, Mandibular advancement device
Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.
| Study group | Role | What they receive |
|---|---|---|
| Midline traction oral appliance | Experimental | Subjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing. Receives: Device: Midline traction oral appliance |
| Control | No intervention | Subjects who do do not wish to wear the oral appliance will have their sleep monitored in parallel to the experimental subjects for 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of stable to unstable sleep from CPC
Ratio of stable to unstable sleep based on cardiopulmonary coupling analysis.
Measured: Two nights of sleep recordings at each of 3 time point over 5 weeks.
Secondary outcomes (5)
Number of snores per hour of sleep
Number of snores and snore index (#snores/hour of sleep)
Measured: At each of 3 time points over 5 weeks
Pittsburgh Sleep Quality Index (PSQI)
Self reported measures concerning sleep over a 1-month period; overall score ranging from 0 to 21; Scores >7 suggests poor sleep quality.
Measured: At baseline and after 5 weeks
Insomnia Sleep Questionnaire (ISQ)
A screening tool used to guide in the clinical evaluation of insomnia; Scores 3, 4 or 5 to two or more items suggests significant daytime impairment and further evaluation of insomnia.
Measured: At baseline and after 5 weeks
Hamilton Depression Rating Scale (HDRS)
Used to provide an indication of depression, and as a guide to evaluate recovery; Higher scores = depression severity. Score >20 suggests depression severity.
Measured: At baseline and after 5 weeks
Fatigue Severity Scale (FSS)
9-item scale which measures the severity of fatigue and its effect on a person's activities; and lifestyle. Higher scores = greater fatigue severity. Minimum score = 9; Maximum score = 63.
Measured: At baseline and after 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Feb 2018
- Primary completion30 Apr 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SnoringStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Controlled clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emet D. Schneiderman, PhD, Texas A&M University
- Investigators
- Emet D Schneiderman, PhD, Principal investigator, Texas A&M University College of DentistryPreetam J Schramm, PhD, Principal investigator, Texas A&M University College of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646214
- Sponsor's protocol ID
- IRB2018-0048
- Acronym
- PREGNCCT
- Status last verified
- Oct 2025
- First submitted
- 27 Jun 2018
- Last updated
- 7 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03646214
- Acronym / sponsor ID
- PREGNCCT / IRB2018-0048
- Conditions
- Snoring, Sleep Fragmentation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 24 Aug 2018 (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.
Many pregnant women suffer from poor sleep quality and snoring. Evidence shows an increasing association between (1) sleep disordered breathing and (2) maternal cardiovascular disease and in-hospital death. Snoring is a variant of obstructive sleep apnea (OSA) and OSA during pregnancy is associated with higher risks for cesarean delivery, gestational hypertension, preeclampsia and preterm delivery. It may also impact fetal outcomes negatively. The purpose of this study is to determine whether sleep quality can be improved in pregnant women who snore by means of an oral appliance that opens the airway. Sleep quality is evaluated objectively using an un-intrusive home sleep test system.
Detailed description
As many as 20 percent of women suffer from snoring and poor sleep quality while pregnant. The purpose of this study is to determine whether sleep can be improved in pregnant women who snore by means of a midline traction oral appliance (OA) that opens the airway. This is an interventional study to objectively evaluate OA therapy on breathing during sleep as well as its effect on sleep quality. Pregnant women from all trimesters will be recruited. Each subject is expected to participate in the study for at least five (5) consecutive weeks. Home sleep recordings will be collected at three time points: T0 - Baseline prior to OA use for two consecutive nights; T1- first two consecutive nights wearing the OA; T2 - for two consecutive nights after 4 weeks of appliance use. In addition to the sleep studies performed at each of these time points, subjects will also complete several brief surveys. All participants will be given the opportunity to use their OAs after the 4 week period, and have their sleep recorded at 8 week intervals through the remainder of their pregnancies. Participants will get to keep and use their OAs after the study.
Pregnant women who snore (or otherwise have poor sleep), may qualify to participate in this study. Those who do not want to wear an oral appliance, but are interested in learning about sleep quality while pregnant, may also qualify to participate as a control subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Midline traction oral appliance | Experimental | Device: Midline traction oral applianceSubjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing. |
| Control | No intervention | –Subjects who do do not wish to wear the oral appliance will have their sleep monitored in parallel to the experimental subjects for 4 weeks. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Pregnant adults who snore
- At least 8 teeth per arch
- Mallampati score from I to II
- Palatine tonsils grade 0,1 or 2
- Capable of giving verbal and written informed consent
Key exclusion criteria (8 listed)
- Pregnant > 32 weeks
- Uncontrolled serious health issues
- Cardiovascular or cardiac rhythm disorders
- Pharmacological dependency
- Concomitant use of hypnotic agents or other sleep aids, nicotine or alcohol
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 |
|---|---|---|
| Midline traction oral applianceAlso: MyTAP oral appliance, Mandibular advancement deviceDevice positions the mandible forward to open airway; device can be titrated to gradually advance the mandible. | Device | Midline traction oral appliance |
Primary outcome
Ratio of stable to unstable sleep from CPC
Time frame: Two nights of sleep recordings at each of 3 time point over 5 weeks.
Ratio of stable to unstable sleep based on cardiopulmonary coupling analysis.
5 secondary outcomes
Number of snores per hour of sleep
Time frame: At each of 3 time points over 5 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: At baseline and after 5 weeks
Insomnia Sleep Questionnaire (ISQ)
Time frame: At baseline and after 5 weeks
Hamilton Depression Rating Scale (HDRS)
Time frame: At baseline and after 5 weeks
Fatigue Severity Scale (FSS)
Time frame: At baseline and after 5 weeks
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 7 Oct 2025.
- Individual participant dataSharing planned: No
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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.
Emet D Schneiderman, PhD principal investigator
Texas A&M University College of Dentistry
Preetam J Schramm, PhD principal investigator
Texas A&M University College of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midline traction oral appliance in people with Snoring and Sleep Fragmentation, run by Texas A&M University 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 6 inclusion and 8 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 7 Oct 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?
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 Zohre German, MS (214-828-8291, german@tamhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of stable to unstable sleep from CPC (time frame: Two nights of sleep recordings at each of 3 time point over 5 weeks.). 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 7 Oct 2025.