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Improving Sleep Quality During Pregnancy Using an Oral Appliance (PREGNCCT)

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ClinicalTrials.gov Identifier: NCT03646214
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
Sponsor:
Information provided by (Responsible Party):
Texas A&M University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Snoring Sleep Fragmentation Device: Midline traction oral appliance Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Controlled clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: Outcomes assessor reading the sleep studies will have the treatment arm masked.
Primary Purpose: Treatment
Official Title: Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial
Actual Study Start Date : February 1, 2018
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Snoring

Arm Intervention/treatment
Experimental: Midline traction oral appliance
Subjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing.
Device: Midline traction oral appliance
Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.
Other Names:
  • MyTAP oral appliance
  • Mandibular advancement device

No Intervention: Control
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.



Primary Outcome Measures :
  1. Sleep quality [ 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.


Secondary Outcome Measures :
  1. Snoring [ Time Frame: At each of 3 time points over 5 weeks ]
    Number of snores and snore index (#snores/hour of sleep)

  2. Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: At baseline and after 5 weeks ]
    Self reported measures concerning sleep over a 1-month period; overall score ranging from 0 to 21; Scores >7 suggests poor sleep quality.

  3. Insomnia Sleep Questionnaire (ISQ) [ Time Frame: At baseline and after 5 weeks ]
    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.

  4. Hamilton Depression Rating Scale (HDRS) [ Time Frame: At baseline and after 5 weeks ]
    Used to provide an indication of depression, and as a guide to evaluate recovery; Higher scores = depression severity. Score >20 suggests depression severity.

  5. Fatigue Severity Scale (FSS) [ Time Frame: At baseline and after 5 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646214


Contacts
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Contact: Zohre German, MS 214-828-8291 german@tamhsc.edu

Locations
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United States, Texas
Texas A&M University College of Dentistry Recruiting
Dallas, Texas, United States, 75246
Contact: Zohre German, MS    214-828-8291    german@tamhsc.edu   
Sub-Investigator: Jason Hui, DDS         
Sub-Investigator: Duane Wilson, DDS         
Sub-Investigator: Ann McCann, PhD         
Sub-Investigator: Pollyana Moura, DDS         
Sponsors and Collaborators
Texas A&M University
Investigators
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Principal Investigator: Emet D Schneiderman, PhD Texas A&M University College of Dentistry
Principal Investigator: Preetam J Schramm, PhD Texas A&M University College of Dentistry

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Responsible Party: Texas A&M University
ClinicalTrials.gov Identifier: NCT03646214     History of Changes
Other Study ID Numbers: IRB2018-0048
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Sleep Deprivation
Snoring
Respiratory Sounds
Signs and Symptoms, Respiratory
Signs and Symptoms
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Neurologic Manifestations
Mental Disorders