Trial Outcomes & Findings for Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy (NCT NCT02755831)

Last Updated: 2019-11-27

Results Overview

Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)

Recruitment status

COMPLETED

Study phase

Target enrollment

193 participants

Primary outcome timeframe

time of delivery

Results posted on

2019-11-27

Participant Flow

Enrollment. There were 714 women assessed for eligibility with N = 193 enrolled; n = 100 allocated to treatment group and n = 93 to the control group. In the treatment group there were n = 3 and n = 3 in the control group, respectively, loss to follow-up. The final analysis included n = 97 in the treatment group and n = 90 in the control group.

Participant milestones

Participant milestones
Measure	Sleep Study + CPAP Group Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea	Standard Prenatal Care Group Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. Pre-natal care: Standard Pre-Natal Care
Overall Study STARTED	100	93
Overall Study COMPLETED	97	90
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Sleep Study + CPAP Group Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea	Standard Prenatal Care Group Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. Pre-natal care: Standard Pre-Natal Care
Overall Study Lost to Follow-up	3	3

Baseline Characteristics

Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sleep Study + CPAP Group n=100 Participants Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea	Standard Prenatal Care Group n=93 Participants Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. Pre-natal care: Standard Pre-Natal Care	Total n=193 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	100 Participants n=5 Participants	93 Participants n=7 Participants	193 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	29.1 years STANDARD_DEVIATION 4.8 • n=5 Participants	28.8 years STANDARD_DEVIATION 5.2 • n=7 Participants	29 years STANDARD_DEVIATION 5 • n=5 Participants
Sex: Female, Male Female	100 Participants n=5 Participants	93 Participants n=7 Participants	193 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) White	43 Participants n=5 Participants	46 Participants n=7 Participants	89 Participants n=5 Participants
Race (NIH/OMB) More than one race	20 Participants n=5 Participants	16 Participants n=7 Participants	36 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants	93 participants n=7 Participants	193 participants n=5 Participants
Pre-Pregnancy BMI	34.5 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants	33.3 kg/m^2 STANDARD_DEVIATION 6.8 • n=7 Participants	33.9 kg/m^2 STANDARD_DEVIATION 7 • n=5 Participants

PRIMARY outcome

Timeframe: time of delivery

Outcome measures

Outcome measures
Measure	Sleep Study + CPAP Group n=97 Participants Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea	Standard Prenatal Care Group n=90 Participants Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. Pre-natal care: Standard Pre-Natal Care
Number of Participants With Adverse Pregnancy Outcomes	45 Participants	39 Participants

SECONDARY outcome

Timeframe: early pregnancy (6-16 weeks)

Population: Friedman's test was used to analyze differences in sleep study results at the three time points in experimental group. If significant differences are found in sleep study results a post hoc Wilcoxon Ranked Sign test will be used to compare differences at individual time points. Data were not collected for Control group at this time point.

Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only. Data were not collected for Control group at this time point.

Outcome measures

Outcome measures
Measure	Sleep Study + CPAP Group n=93 Participants Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea	Standard Prenatal Care Group Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. Pre-natal care: Standard Pre-Natal Care
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks) No OSA	89 Participants	—
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks) mild OSA	3 Participants	—
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks) moderate OSA	0 Participants	—
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks) severe OSA	1 Participants	—

SECONDARY outcome

Timeframe: 27-33 weeks

Population: Incidence and Severity of OSA in Late Pregnancy. Outcome data was only collected in the treatment group. Data were not collected for Control group at this time point

Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks). Data were not collected for Control group at this time point

Outcome measures

Outcome measures
Measure	Sleep Study + CPAP Group n=92 Participants Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea	Standard Prenatal Care Group Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. Pre-natal care: Standard Pre-Natal Care
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) No OSA	81 Participants	—
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) Mild OSA	11 Participants	—
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) Moderate OSA	0 Participants	—
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks) Severe OSA	0 Participants	—

SECONDARY outcome

Timeframe: 8-12 weeks postpartum

Population: Incidence and Severity of OSA at 8-12 weeks postpartum. This is the only time point in which both groups completed sleep studies.

Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.

Outcome measures

Outcome measures
Measure	Sleep Study + CPAP Group n=89 Participants Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea	Standard Prenatal Care Group n=80 Participants Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. Pre-natal care: Standard Pre-Natal Care
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group No OSA	72 Participants	69 Participants
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group mild OSA	14 Participants	9 Participants
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group Moderate OSA	2 Participants	2 Participants
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group Severe OSA	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Hospital costs at time of delivery

Hospital costs at time of delivery in treatment and control group.

Outcome measures

Outcome measures
Measure	Sleep Study + CPAP Group n=97 Participants Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment CPAP: Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea	Standard Prenatal Care Group n=90 Participants Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. Pre-natal care: Standard Pre-Natal Care
Hospital Costs at Time of Delivery	12185 dollars Interval 11155.0 to 13215.0	12607 dollars Interval 11210.0 to 14004.0

Adverse Events

Sleep Study + CPAP Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Prenatal Care Group

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

CAPTAIN Dennis Spence, NC, USN, PhD, CRNA

Naval Medical Center San Diego

Phone: 6199161680

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place