Trial Outcomes & Findings for Sleep-Disordered Breathing and PAP in Perinatal Depression (NCT NCT02507297)

NCT ID: NCT02507297

Last Updated: 2023-05-01

Results Overview

Change in clinician-rated depression severity and symptoms, excluding the items which measure sleep. Total score range: 0-46. Higher scores represent more severe depression.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 29 participants
• Primary outcome timeframe: Baseline to 8 weeks after baseline, and at 12 weeks postpartum
• Results posted on: 2023-05-01

Participant Flow

Participant milestones

Measure	PAP Group Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.	TAU Group Treatment as usual through obstetrics
Overall Study STARTED	16	13
Overall Study COMPLETED	15	12
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	PAP Group Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.	TAU Group Treatment as usual through obstetrics
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Sleep-Disordered Breathing and PAP in Perinatal Depression

Baseline characteristics by cohort

Measure	PAP Group n=16 Participants Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.	TAU Group n=13 Participants Treatment as usual through obstetrics	Total n=29 Participants Total of all reporting groups
Age, Continuous	31.44 years STANDARD_DEVIATION 5.39 • n=5 Participants	27.31 years STANDARD_DEVIATION 6.32 • n=7 Participants	29.18 years STANDARD_DEVIATION 5.95 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	13 Participants n=7 Participants	29 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	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Hamilton Rating Scale for Depression (HRSD) Score, Excluding the Sleep Items	15.06 units on a scale STANDARD_DEVIATION 3.87 • n=5 Participants	14.69 units on a scale STANDARD_DEVIATION 3.68 • n=7 Participants	14.9 units on a scale STANDARD_DEVIATION 3.73 • n=5 Participants
Edinburgh Postnatal Depression Scale (EPDS) Score, Minus the Sleep Item	11.88 units on a scale STANDARD_DEVIATION 3.79 • n=5 Participants	14.15 units on a scale STANDARD_DEVIATION 3.76 • n=7 Participants	12.9 units on a scale STANDARD_DEVIATION 3.89 • n=5 Participants
Pittsburgh Sleep Quality Index (PSQI) Score	9.63 units on a scale STANDARD_DEVIATION 2.99 • n=5 Participants	10.92 units on a scale STANDARD_DEVIATION 3.12 • n=7 Participants	10.21 units on a scale STANDARD_DEVIATION 3.06 • n=5 Participants
Epworth Sleepiness Scale (ESS) Score	12.44 units on a scale STANDARD_DEVIATION 4.03 • n=5 Participants	8.54 units on a scale STANDARD_DEVIATION 4.16 • n=7 Participants	10.69 units on a scale STANDARD_DEVIATION 4.47 • n=5 Participants
Salivary cortisol	33.07 nmol/L STANDARD_DEVIATION 6.89 • n=5 Participants	33.02 nmol/L STANDARD_DEVIATION 10.82 • n=7 Participants	33.05 nmol/L STANDARD_DEVIATION 8.69 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline to 8 weeks after baseline, and at 12 weeks postpartum

Population: Data are not available for 3 participants of the 16 participants started in the PAP group at baseline to 8 weeks. Data are not available for 3 participants of the 16 participants started in the PAP group at baseline to 12 weeks and 2 participants of the 13 participants started in the TAU group at baseline to 12 weeks postpartum.

Change in clinician-rated depression severity and symptoms, excluding the items which measure sleep. Total score range: 0-46. Higher scores represent more severe depression.

Outcome measures

Measure	PAP Group n=13 Participants Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.	TAU Group n=13 Participants Treatment as usual through obstetrics
Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item Baseline to 8 weeks after baseline	-7.62 change in score Standard Deviation 5.65	-5.92 change in score Standard Deviation 3.47
Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item Baseline to 12 weeks postpartum	-8.21 change in score Standard Deviation 7.39	-6.18 change in score Standard Deviation 6.51

SECONDARY outcome

Timeframe: Baseline to 8 weeks after baseline, and at 12 weeks postpartum

Population: Data for the baseline to 12 weeks postpartum analysis are not available for 3 participants of the 13 participants started in the TAU group and for 2 participants of the 16 participants started in the PAP group.

Change in a self-report measure of depression symptoms and severity. Total scores range from 0 to 27; higher scores indicate more severe depression.

Outcome measures

Measure	PAP Group n=16 Participants Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.	TAU Group n=13 Participants Treatment as usual through obstetrics
Change in Edinburgh Postnatal Depression Scale Score Baseline to 8 weeks after baseline	-4.13 score on a scale Standard Deviation 3.11	-2.23 score on a scale Standard Deviation 3.51
Change in Edinburgh Postnatal Depression Scale Score Baseline to 12 weeks postpartum	-3.00 score on a scale Standard Deviation 3.88	-5.00 score on a scale Standard Deviation 5.85

SECONDARY outcome

Timeframe: Baseline to 8 weeks after baseline, and at 12 weeks postpartum

Population: Data for 2 participants of the 16 participants started in the PAP group are not available in the baseline to 8 weeks after baseline analysis and data for 3 participants from the 13 participants started in the TAU group are not available in the baseline to 8 weeks after baseline analysis. Data from 3 participants from the 13 participants started in the TAU group and 2 participants of the 16 participants started in the PAP group are not available in the baseline to 12 weeks analysis.

Change in a measure of sleep quality. Total scores range from 0 to 21. Higher scores indicate worse sleep quality.

Outcome measures

Measure	PAP Group n=14 Participants Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.	TAU Group n=13 Participants Treatment as usual through obstetrics
Change in Pittsburgh Sleep Quality Index Score Baseline to 8 weeks after baseline	-1.64 score on a scale Standard Deviation 3.10	-1.80 score on a scale Standard Deviation 4.16
Change in Pittsburgh Sleep Quality Index Score Baseline to 12 weeks postpartum	-1.29 score on a scale Standard Deviation 3.67	-1.8 score on a scale Standard Deviation 4.16

SECONDARY outcome

Timeframe: Baseline to 8 weeks after baseline, and at 12 weeks postpartum

Population: Data are not available for 2 participants of the 16 participants started in the PAP group at baseline to 8 weeks and 3 participants of the 13 participants started in the TAU group at baseline to 8 weeks. Data are not available for 2 participants of the 16 participants started in the PAP group at baseline to 12 weeks and 3 participants of the 13 participants started in the TAU group at baseline to 12 weeks postpartum.

Change in a measure of excessive daytime sleepiness. Scores range from 0 to 25. Higher scores indicate more daytime sleepiness.

Outcome measures

Measure	PAP Group n=14 Participants Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.	TAU Group n=10 Participants Treatment as usual through obstetrics
Change in Epworth Sleepiness Scale (ESS) Score Baseline to 8 weeks after baseline	-2.14 change in score Standard Deviation 4.14	-1.00 change in score Standard Deviation 5.54
Change in Epworth Sleepiness Scale (ESS) Score Baseline to 12 weeks postpartum	-2.14 change in score Standard Deviation 4.15	-1 change in score Standard Deviation 5.54

SECONDARY outcome

Timeframe: Baseline to 8 weeks after baseline

Population: Data are not available for 4 participants of the 16 participants started in the PAP group and 3 participants of the 13 participants started in the TAU group.

Salivary cortisol is a hormone produced by the adrenal gland. Values are in nmol/L; detectable assay range is 0.33 - 82.77 nmol/L. Higher values indicate higher levels of cortisol.

Outcome measures

Measure	PAP Group n=12 Participants Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.	TAU Group n=10 Participants Treatment as usual through obstetrics
Change in Salivary Cortisol	-1.23 nmol/L Standard Deviation 7.23	1.38 nmol/L Standard Deviation 9.98

Adverse Events

PAP Group

Serious events: 3 serious events

Other events: 10 other events

Deaths: 0 deaths

TAU Group

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	PAP Group n=16 participants at risk Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.	TAU Group n=13 participants at risk Treatment as usual through obstetrics
Pregnancy, puerperium and perinatal conditions Stillbirth	6.2% 1/16 • Number of events 1 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	0.00% 0/13 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Hepatobiliary disorders Hyperbilirubinemia	6.2% 1/16 • Number of events 1 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	0.00% 0/13 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Reproductive system and breast disorders Postpartum hemorrhage	6.2% 1/16 • Number of events 1 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	0.00% 0/13 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.

Other adverse events

Measure	PAP Group n=16 participants at risk Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Positive Airway Pressure (PAP): Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.	TAU Group n=13 participants at risk Treatment as usual through obstetrics
Skin and subcutaneous tissue disorders Skin irritation	31.2% 5/16 • Number of events 5 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	— 0/0 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Gastrointestinal disorders Dry mouth	6.2% 1/16 • Number of events 1 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	— 0/0 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Respiratory, thoracic and mediastinal disorders Nasal congestion	6.2% 1/16 • Number of events 1 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	— 0/0 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Psychiatric disorders Claustrophobia	12.5% 2/16 • Number of events 2 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	— 0/0 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Nervous system disorders Insomnia	12.5% 2/16 • Number of events 2 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	— 0/0 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Psychiatric disorders Depression	25.0% 4/16 • Number of events 4 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	23.1% 3/13 • Number of events 3 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Pregnancy, puerperium and perinatal conditions Diabetes mellitus	12.5% 2/16 • Number of events 2 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	7.7% 1/13 • Number of events 1 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Pregnancy, puerperium and perinatal conditions Premature delivery	6.2% 1/16 • Number of events 1 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	15.4% 2/13 • Number of events 2 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Pregnancy, puerperium and perinatal conditions Small for gestational age (infant)	0.00% 0/16 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	7.7% 1/13 • Number of events 1 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.
Psychiatric disorders Anxiety	0.00% 0/16 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.	7.7% 1/13 • Number of events 1 • Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study). Participants were queried about adverse events each time they completed the clinical assessment (Hamilton Rating Scale for Depression). Adverse event information was also obtained from participants' medical records. Note that participants in the TAU group were not at risk for the adverse events related to positive airway pressure (PAP) treatment as they were not assigned to receive PAP treatment; these adverse events are denoted by a 0 in the denominator for at risk designation for TAU group.

Additional Information

Leslie Swanson

University of Michigan

Phone: 734-764-2242

Email: lmswan@umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place