Improving Sleep Quality During Pregnancy Using an Oral Appliance

Snoring Clinical Trial

— PREGNCCT  

Official title:

Oral Appliance Therapy for Improving Sleep Quality During Pregnancy: A Controlled Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03646214
• Other study ID #: IRB2018-0048
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: December 31, 2023

Study information

• Verified date: October 2022
• Source: Texas A&M University
• Contact: Zohre German, MS
• Phone: 214-828-8291
• Email: german[@]tamhsc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2023
• Est. primary completion date: March 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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)

Related Conditions & MeSH terms

• Sleep Deprivation
• Sleep Fragmentation
• Snoring

Intervention

Device:
• Midline traction oral appliance
Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.

Locations

Country	Name	City	State
United States	Texas A&M University College of Dentistry	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Texas A&M University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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