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The goal of this study is to understand the contribution of sleep-disordered breathing (SDB) to one of the most common and debilitating adverse pregnancy outcomes, perinatal depression. The study is a randomized trial to test the efficacy of positive airway pressure (PAP) on sleep and depression symptoms in perinatal women. Participants will be pregnant women with depression and sleep-disordered breathing. Participants will be randomly assigned to receive either PAP therapy (PAP group) or treatment as usual within obstetrics (TAU group). Mood and sleep assessments will be completed at baseline, after 1 week of enrollment, and monthly thereafter through 12 weeks postpartum. Cortisol will be measured using saliva collection at baseline and again 8 weeks later.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PAP Group | Experimental | Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly |
|
| TAU Group | No Intervention | Treatment as usual through obstetrics |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Positive Airway Pressure (PAP) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item | 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. | Baseline to 8 weeks after baseline, and at 12 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Edinburgh Postnatal Depression Scale Score | Change in a self-report measure of depression symptoms and severity. Total scores range from 0 to 27; higher scores indicate more severe depression. | Baseline to 8 weeks after baseline, and at 12 weeks postpartum |
| Change in Pittsburgh Sleep Quality Index Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leslie Swanson, Ph.D. | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | TAU Group | Treatment as usual through obstetrics |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item | 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. | 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. | Posted | Mean | Standard Deviation | change in score | Baseline to 8 weeks after baseline, and at 12 weeks postpartum |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA (10.0) | Systematic Assessment | Skin irritation specifically related to CPAP mask |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leslie Swanson | University of Michigan | 734-764-2242 | lmswan@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2020 | Mar 24, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
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|
|
Change in a measure of sleep quality. Total scores range from 0 to 21. Higher scores indicate worse sleep quality. |
| Baseline to 8 weeks after baseline, and at 12 weeks postpartum |
| Change in Epworth Sleepiness Scale (ESS) Score | Change in a measure of excessive daytime sleepiness. Scores range from 0 to 25. Higher scores indicate more daytime sleepiness. | Baseline to 8 weeks after baseline, and at 12 weeks postpartum |
| Change in Salivary Cortisol | 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. | Baseline to 8 weeks after baseline |
| BG001 | TAU Group | Treatment as usual through obstetrics |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Hamilton Rating Scale for Depression (HRSD) Score, Excluding the Sleep Items | Clinician-rated depression severity and symptoms, excluding the items which measure sleep. Total score range: 0-46. Higher scores represent more severe depression. | Mean | Standard Deviation | units on a scale |
|
| Edinburgh Postnatal Depression Scale (EPDS) Score, Minus the Sleep Item | Self-reported measure of depression symptoms and severity, minus the sleep item. Total scores range from 0 to 27; higher scores indicate more severe depression. | Mean | Standard Deviation | units on a scale |
|
| Pittsburgh Sleep Quality Index (PSQI) Score | Measure of sleep quality. Total scores range from 0 to 21. Higher scores indicate worse sleep quality. | Mean | Standard Deviation | units on a scale |
|
| Epworth Sleepiness Scale (ESS) Score | Measure of excessive daytime sleepiness. Scores range from 0 to 25. Higher scores indicate more daytime sleepiness. | Mean | Standard Deviation | units on a scale |
|
| Salivary cortisol | 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. | Mean | Standard Deviation | nmol/L |
|
| OG001 | TAU Group | Treatment as usual through obstetrics |
|
|
|
| Secondary | Change in Edinburgh Postnatal Depression Scale Score | Change in a self-report measure of depression symptoms and severity. Total scores range from 0 to 27; higher scores indicate more severe depression. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 8 weeks after baseline, and at 12 weeks postpartum |
|
|
|
|
| Secondary | Change in Pittsburgh Sleep Quality Index Score | Change in a measure of sleep quality. Total scores range from 0 to 21. Higher scores indicate worse sleep quality. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to 8 weeks after baseline, and at 12 weeks postpartum |
|
|
|
|
| Secondary | Change in Epworth Sleepiness Scale (ESS) Score | Change in a measure of excessive daytime sleepiness. Scores range from 0 to 25. Higher scores indicate more daytime sleepiness. | 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. | Posted | Mean | Standard Deviation | change in score | Baseline to 8 weeks after baseline, and at 12 weeks postpartum |
|
|
|
|
| Secondary | Change in Salivary Cortisol | 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. | 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. | Posted | Mean | Standard Deviation | nmol/L | Baseline to 8 weeks after baseline |
|
|
|
|
| 0 |
| 16 |
| 3 |
| 16 |
| 10 |
| 16 |
| EG001 | TAU Group | Treatment as usual through obstetrics | 0 | 13 | 0 | 13 | 6 | 13 |
| Hyperbilirubinemia | Hepatobiliary disorders | MedDRA (10.0) | Systematic Assessment | Hyperbilirubinemia in participant's infant requiring hospitalization of infant |
|
| Postpartum hemorrhage | Reproductive system and breast disorders | MedDRA (10.0) | Systematic Assessment |
|
|
| Dry mouth | Gastrointestinal disorders | MedDRA (10.0) | Systematic Assessment | Dry mouth specifically related to CPAP usage |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Systematic Assessment | Nasal congestion specifically related to CPAP usage |
|
| Claustrophobia | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment | Claustrophobia when using CPAP mask |
|
| Insomnia | Nervous system disorders | MedDRA (10.0) | Systematic Assessment | Insomnia specifically related to using CPAP or to in-lab sleep night (only PAP participants completed the in-lab sleep night) |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment | Worsening of depression from baseline |
|
| Diabetes mellitus | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment | Gestational diabetes |
|
| Premature delivery | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment |
|
| Small for gestational age (infant) | Pregnancy, puerperium and perinatal conditions | MedDRA (10.0) | Systematic Assessment | Participant's infant was small for gestational age |
|
| Anxiety | Psychiatric disorders | MedDRA (10.0) | Systematic Assessment | Distress/anxiety in completing study questionnaires |
|
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| D020920 |
| Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| Baseline to 12 weeks postpartum |
|
|
| .324 |
| Superiority |
| Baseline to 12 weeks postpartum |
|
|
| .752 |
| Superiority |
| .568 |
| Superiority |