Obstructive Sleep Apnea in Pregnancy

NCT02383706 | Completed Results

• 1 other identifier: Pro00056786
• Study Type: observational
• Target: 108
• Locations: 1 country
• Sites: 1

Brief Summary

Obstructive sleep apnea (OSA) is a risk factor for complications during pregnancy and current screening tools for OSA have not been shown to be reliable in pregnant women. The primary aim of this study is to develop a valid screening tool to identify at-risk pregnant women, so that they can be further evaluated and treated. Women with OSA may also be at risk for respiratory complications related to opiate administration for post-cesarean delivery pain. A secondary aim of this study is to evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring.

Conditions

Sleep Apnea, Obstructive; Pregnancy; Obesity, Morbid

Keywords

Sleep Apnea, Obstructive; Pregnancy; Obesity, Morbid; Complications, pregnancy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result

  Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-negative if experienced less than five events per hour.

  Women studied at one time point between 24 weeks and 35 weeks gestation.

• Number of Participants With a Positive Obstructive Sleep Apnea (OSA) Home Sleep Test Result

  Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-positive if experienced five or more events per hour.

  Women studied at one time point between 24 weeks and 35 weeks gestation.

Secondary Outcomes (1)

• Post-op Minute Ventilation Following C-section

  Women studied for 24-hours following their cesarean delivery.

Study Arms (1)

Subjects

Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.

Device: ApneaLink Air; Behavioral: Berlin Quesionnaire; Behavioral: Epworth Sleepiness Scale; Behavioral: STOP-BANG questionnaire; Other: Physical exam

Interventions

ApneaLink Air DEVICE

Overnight, home polysomnography device

Subjects

Berlin Quesionnaire BEHAVIORAL

OSA screening questionnaire

Subjects

Epworth Sleepiness Scale BEHAVIORAL

OSA screening questionnaire

Subjects

STOP-BANG questionnaire BEHAVIORAL

OSA screening questionnaire

Subjects

Physical exam OTHER

Physical exam of neck, mouth and upper airway

Subjects

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women, ages 18-50 years old, BMI \> or equal to 40 kg/m2, without a prior diagnosis of obstructive sleep apnea or chronic narcotic use.

You may qualify if:

• gestational age 24 to 35 weeks
• BMI \> or equal to 40 kg/m2
• years or older

You may not qualify if:

• Non-English speaking subjects
• Established diagnosis of OSA
• chronic narcotic use

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Related Publications (1)

• Dominguez JE, Grotegut CA, Cooter M, Krystal AD, Habib AS. Screening extremely obese pregnant women for obstructive sleep apnea. Am J Obstet Gynecol. 2018 Dec;219(6):613.e1-613.e10. doi: 10.1016/j.ajog.2018.09.001. Epub 2018 Sep 11.

  PMID: 30217579 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Obesity, Morbid; Pregnancy Complications

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Limitations and Caveats

80 subjects Home sleep testing used Low acceptance of home sleep test by subjects (28 subjects did not wear device more than 2 hours) One time point in pregnancy

Results Point of Contact

• Title: Dr Jennifer Dominguez
• Organization: Duke University Medical Center

jennifer.dominguez@dm.duke.edu

(919) 668-2024

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2015
• First Posted: March 9, 2015
• Study Start: February 1, 2015
• Primary Completion: May 1, 2017
• Study Completion: August 1, 2017
• Last Updated: June 19, 2019
• Results First Posted: June 19, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)