Trial Outcomes & Findings for Obstructive Sleep Apnea in Pregnancy (NCT NCT02383706)
NCT ID: NCT02383706
Last Updated: 2019-06-19
Results Overview
Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-negative if experienced less than five events per hour.
Recruitment status
COMPLETED
Target enrollment
108 participants
Primary outcome timeframe
Women studied at one time point between 24 weeks and 35 weeks gestation.
Results posted on
2019-06-19
Participant Flow
Participant milestones
| Measure |
Subjects
Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.
ApneaLink Air: Overnight, home polysomnography device
Berlin Quesionnaire: OSA screening questionnaire
Epworth Sleepiness Scale: OSA screening questionnaire
STOP-BANG questionnaire: OSA screening questionnaire
Physical exam: Physical exam of neck, mouth and upper airway
|
|---|---|
|
Overall Study
STARTED
|
108
|
|
Overall Study
COMPLETED
|
80
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reported separately for participants with Obstructive Sleep Apnea and those without.
Baseline characteristics by cohort
| Measure |
Subjects
n=80 Participants
Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.
ApneaLink Air: Overnight, home polysomnography device
Berlin Quesionnaire: OSA screening questionnaire
Epworth Sleepiness Scale: OSA screening questionnaire
STOP-BANG questionnaire: OSA screening questionnaire
Physical exam: Physical exam of neck, mouth and upper airway
|
|---|---|
|
Age, Continuous
No Obstructive Sleep Apnea
|
27 years
n=61 Participants • Reported separately for participants with Obstructive Sleep Apnea and those without.
|
|
Age, Continuous
Obstructive Sleep Apnea
|
33 years
n=19 Participants • Reported separately for participants with Obstructive Sleep Apnea and those without.
|
|
Age, Continuous
All subjects
|
29.5 years
n=80 Participants • Reported separately for participants with Obstructive Sleep Apnea and those without.
|
|
Sex: Female, Male
Female
|
80 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
78 Participants
n=80 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Black or African American
|
52 Participants
n=80 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=80 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=80 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=80 Participants
|
|
Region of Enrollment
United States
|
80 Participants
n=80 Participants
|
|
Pre-pregnancy Body Mass Index (BMI)
Obstructive Sleep Apnea
|
53 kg/m^2
n=19 Participants • Reported separately for participants with Obstructive Sleep Apnea and those without.
|
|
Pre-pregnancy Body Mass Index (BMI)
No Obstructive Sleep Apnea
|
45 kg/m^2
n=61 Participants • Reported separately for participants with Obstructive Sleep Apnea and those without.
|
|
Pre-pregnancy Body Mass Index (BMI)
All subjects
|
46 kg/m^2
n=80 Participants • Reported separately for participants with Obstructive Sleep Apnea and those without.
|
PRIMARY outcome
Timeframe: Women studied at one time point between 24 weeks and 35 weeks gestation.Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-negative if experienced less than five events per hour.
Outcome measures
| Measure |
Subjects
n=80 Participants
Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.
ApneaLink Air: Overnight, home polysomnography device Berlin Quesionnaire: OSA screening questionnaire Epworth Sleepiness Scale: OSA screening questionnaire STOP-BANG questionnaire: OSA screening questionnaire Physical exam: Physical exam of neck, mouth and upper airway
|
|---|---|
|
Number of Participants With a Negative Obstructive Sleep Apnea (OSA) Home Sleep Test Result
|
61 Participants
|
PRIMARY outcome
Timeframe: Women studied at one time point between 24 weeks and 35 weeks gestation.Determined using the Apnea-Hypopnea Index (AHI). Participants were considered OSA-positive if experienced five or more events per hour.
Outcome measures
| Measure |
Subjects
n=80 Participants
Pregnant women, BMI greater than or equal to 40 undergo questionnaires, physical exam, and ApneaLink Air, at home, overnight polysomnography study.
ApneaLink Air: Overnight, home polysomnography device Berlin Quesionnaire: OSA screening questionnaire Epworth Sleepiness Scale: OSA screening questionnaire STOP-BANG questionnaire: OSA screening questionnaire Physical exam: Physical exam of neck, mouth and upper airway
|
|---|---|
|
Number of Participants With a Positive Obstructive Sleep Apnea (OSA) Home Sleep Test Result
|
19 Participants
|
SECONDARY outcome
Timeframe: Women studied for 24-hours following their cesarean delivery.Population: Data not collected
To evaluate post-operative minute ventilation in women who undergo cesarean delivery using a novel method of non-invasive minute ventilation monitoring
Outcome measures
Outcome data not reported
Adverse Events
Subjects
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place