Improving Sleep Quality During Pregnancy Using an Oral Appliance (PREGNCCT)
Primary Purpose
Snoring, Sleep Fragmentation
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Midline traction oral appliance
Sponsored by
About this trial
This is an interventional treatment trial for Snoring
Eligibility 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)
Sites / Locations
- Texas A&M University College of DentistryRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Midline traction oral appliance
Control
Arm Description
Subjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing.
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.
Outcomes
Primary Outcome Measures
Ratio of stable to unstable sleep from CPC
Ratio of stable to unstable sleep based on cardiopulmonary coupling analysis.
Secondary Outcome Measures
Number of snores per hour of sleep
Number of snores and snore index (#snores/hour of sleep)
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03646214
Brief Title
Improving Sleep Quality During Pregnancy Using an Oral Appliance
Acronym
PREGNCCT
Official Title
Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
March 11, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Texas A&M University
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Snoring, Sleep Fragmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Controlled clinical trial
Masking
Outcomes Assessor
Masking Description
Outcomes assessor reading the sleep studies will have the treatment arm masked.
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Midline traction oral appliance
Arm Type
Experimental
Arm Description
Subjects will wear the oral appliance nightly for 4 weeks. Must snore or have other evidence of sleep disordered breathing.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Midline traction oral appliance
Other Intervention Name(s)
MyTAP oral appliance, Mandibular advancement device
Intervention Description
Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.
Primary Outcome Measure Information:
Title
Ratio of stable to unstable sleep from CPC
Description
Ratio of stable to unstable sleep based on cardiopulmonary coupling analysis.
Time Frame
Two nights of sleep recordings at each of 3 time point over 5 weeks.
Secondary Outcome Measure Information:
Title
Number of snores per hour of sleep
Description
Number of snores and snore index (#snores/hour of sleep)
Time Frame
At each of 3 time points over 5 weeks
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Self reported measures concerning sleep over a 1-month period; overall score ranging from 0 to 21; Scores >7 suggests poor sleep quality.
Time Frame
At baseline and after 5 weeks
Title
Insomnia Sleep Questionnaire (ISQ)
Description
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.
Time Frame
At baseline and after 5 weeks
Title
Hamilton Depression Rating Scale (HDRS)
Description
Used to provide an indication of depression, and as a guide to evaluate recovery; Higher scores = depression severity. Score >20 suggests depression severity.
Time Frame
At baseline and after 5 weeks
Title
Fatigue Severity Scale (FSS)
Description
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.
Time Frame
At baseline and after 5 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zohre German, MS
Phone
214-828-8291
Email
german@tamhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emet D Schneiderman, PhD
Organizational Affiliation
Texas A&M University College of Dentistry
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Preetam J Schramm, PhD
Organizational Affiliation
Texas A&M University College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas A&M University College of Dentistry
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zohre German, MS
Phone
214-828-8291
Email
german@tamu.edu
First Name & Middle Initial & Last Name & Degree
Jason Hui, DDS
First Name & Middle Initial & Last Name & Degree
Duane Wilson, DDS
First Name & Middle Initial & Last Name & Degree
Ann McCann, PhD
First Name & Middle Initial & Last Name & Degree
Pollyana Moura, DDS
12. IPD Sharing Statement
Plan to Share IPD
No
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Improving Sleep Quality During Pregnancy Using an Oral Appliance
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