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

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.

Study Overview

• Status: Recruiting
• Conditions: Snoring; Sleep Fragmentation
• Intervention / Treatment: Device: Midline traction oral appliance

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zohre German, MS; Phone Number: 214-828-8291; Email: german@tamhsc.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75246
      • Recruiting
      • Texas A&M University College of Dentistry
      • Contact: Zohre German, MS; Phone Number: 214-828-8291; Email: german@tamu.edu
      • Sub-Investigator: Jason Hui, DDS
      • Sub-Investigator: Duane Wilson, DDS
      • Sub-Investigator: Ann McCann, PhD
      • Sub-Investigator: Pollyana Moura, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of stable to unstable sleep from CPC	Ratio of stable to unstable sleep based on cardiopulmonary coupling analysis.	Two nights of sleep recordings at each of 3 time point over 5 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of snores per hour of sleep	Number of snores and snore index (#snores/hour of sleep)	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.	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.	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.	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.	At baseline and after 5 weeks

Collaborators and Investigators

• Sponsor: Texas A&M University
• Investigators: 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2018
• Primary Completion (ANTICIPATED): March 11, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: June 27, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (ACTUAL): August 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2022
• Last Update Submitted That Met QC Criteria: October 28, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Signs and Symptoms, Respiratory; Respiratory Sounds; Snoring; Sleep Deprivation
• Other Study ID Numbers: IRB2018-0048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No