Snoring Clinical Trial - Improving Sleep Quality During Pregnancy Using an

Status Recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03646214
Study type	Interventional
Source	Texas A&M University
Contact	Zohre German, MS
Phone	214-828-8291
Email	german@tamhsc.edu
Status	Recruiting
Phase	N/A
Start date	February 1, 2018
Completion date	December 31, 2023

View Details

See also
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Completed	`NCT03964324` - NO Measurements in Screening for Asthma and OSA, in Patients With Severe Snoring	N/A
Completed	`NCT06186687` - Rehabilitative Approaches: Myofunctional Therapy and Retropalatal Narrowing and Snoring	N/A
Completed	`NCT03640793` - Prospective Evaluation of a Palato-Pharyngeal Implant System (PPIS) Obstructive Sleep Apnea Syndrome (OSAS)	N/A
Completed	`NCT03333876` - In Home Assessment of Three Anti-Snoring Devices, a Cross Over Study	N/A
Not yet recruiting	`NCT04143022` - Evaluation of the Effects of Acupuncture Press Needle in Mild to Moderate Obstructive Sleep Apnea Patients	N/A
Completed	`NCT02834767` - Genioglossus Muscle Training for Snoring and Obstructive Sleep Apnea	N/A
Terminated	`NCT01772017` - A Trial to Evaluate a Device for the Treatment of OSA and Snoring	N/A
Withdrawn	`NCT01680380` - Tracking Breathing During Sleep With Non-contact Sensors	N/A
Unknown status	`NCT00806637` - Vessel Sealing System Uvulopalatoplasty Versus Uvulopalatal Flap	N/A
Completed	`NCT00560859` - Childhood Adenotonsillectomy Study for Children With OSAS	N/A
Terminated	`NCT03701165` - The Effect of the DryMouth Shield on Snoring	N/A
Active, not recruiting	`NCT05643352` - Barbed Reposition Pharyngoplasty in Patients Complaining of Unilevel Palatal Snoring	N/A
Recruiting	`NCT05756647` - Mandibular Advancement vs Home Treatment for Primary Snoring	Phase 2
Completed	`NCT04086407` - Apnea Hypopnea Index Severity Versus Head Position During Sleep	N/A
Not yet recruiting	`NCT05116657` - Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome
Completed	`NCT01491828` - Study to Determine Results of Vibratory Stimulus on Subject's Neck	Phase 1
Completed	`NCT01322334` - Singing Exercises to Improve Symptoms of Snoring and Sleep Apnea	N/A
Terminated	`NCT03316963` - Neostigmine For Snoring During DISE	Early Phase 1

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Improving Sleep Quality During Pregnancy Using an Oral Appliance — PREGNCCT

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms