Sleep-Disordered Breathing and PAP in Perinatal Depression
Phase: NA
Conditions: Sleep-disordered Breathing, Major Depressive Disorder
Sponsor: University of Michigan

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Sleep-Disordered Breathing and PAP in Perinatal Depression  
Principal Investigator:  Leslie Swanson, Ph.D. 
Supported by: National Institutes of Health 
NCT02507297 
 
 

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TABLE OF CONTENTS 
Page 
TABLE OF CONTENTS ............................................................................................................. 2 
PRÉCIS ....................................................................................................................................... 3 
1. STUDY OBJECTIVES ............................................................................................................. 4 
1.1 
Primary Objectives .......................................................................................................... 4 
1.2 
Secondary Objectives ...................................................................................................... 4 
2. BACKGROUND AND RATIONALE .................................................................................... 4 
2.1 
Background on Condition, Disease, or Other Primary Study Focus .............................. 4 
2.2 
Study Rationale ............................................................................................................... 5 
3. STUDY DESIGN ....................................................................................................................... 6 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS ................................................ 7 
4.1 
Inclusion Criteria ............................................................................................................ 8 
4.2 
Exclusion Criteria ........................................................................................................... 8 
4.3 
Study Enrollment Procedures ......................................................................................... 8 
5. STUDY INTERVENTIONS .................................................................................................... 8 
5.1 
Interventions, Administration, and Duration .................................................................. 8 
5.2 
Concomitant Interventions .............................................................................................. 9 
5.3 
Adherence Assessment ................................................................................................... 9 
6. STUDY PROCEDURES ........................................................................................................ 10 
6.1 
Schedule of Evaluations ................................................................................................ 10 
6.2 
Description of Evaluations ............................................................................................ 11 
6.2.1  Screening Evaluation ................................................................................................ 11 
6.2.3  Blinding..................................................................................................................... 13 
6.2.4  Follow-up Visits........................................................................................................ 13 
6.2.5  Completion/Final Evaluation .................................................................................... 15 
7. STATISTICAL CONSIDERATIONS .................................................................................. 16 
7.1 
Data Analyses ............................................................................................................... 16 
8. DATA SAFETY MONITORING BOARD .......................................................................... 17 
9. REFERENCES ........................................................................................................................ 17 

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PRÉCIS  
Sleep and Perinatal Depression  
 Objectives  
1.  Assess the impact of positive airway pressure (PAP) on depressive symptoms in 
women with prenatal sleep-disordered breathing (SDB) and depression.  
Hypothesis: The PAP group, in comparison to the non-PAP group, will demonstrate 
improvements in depressive symptoms and more frequent remission of depression, as 
well as improved sleep quality, reduced sleep fragmentation, and increased sleep 
duration.   
 
2. Characterize the effect of PAP on the HPA axis in women with prenatal SDB and 
depression.   
Hypothesis: Use of PAP will reduce levels of cortisol, a marker of HPA axis functioning, 
and reductions in cortisol will correlate with improvements in mood.  
 
3. An additional, exploratory aim is to assess associations between PAP treatment and 
adverse pregnancy and neonatal outcomes.  
We hypothesize that the PAP group in comparison to the non-PAP group will show better 
delivery outcomes (lower rates of preterm birth, shorter hospitalization) and their infants 
will demonstrate greater neurodevelopment relative to those born to the non-PAP group.  
 
Design and Outcomes   
The study is a randomized trial to test the efficacy of PAP on sleep and depression 
symptoms in perinatal women. 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. Blood will be drawn at baseline and again eight weeks later.  
Interventions and Duration  
Participants will be randomly assigned to PAP or treatment as usual.  
Participants assigned to the PAP arm of the study will be offered PAP therapy using an 
auto-titrating device. Participants will receive the first night of therapy in the Sleep 
Laboratory. Participants will use PAP at home for the remainder of their pregnancy and 
through 12 weeks postpartum. 
Participants in the treatment as usual arm will continue their clinical care as usual through 
obstetrics. Note that PAP is not part of treatment as usual/standard care through 
obstetrics. 
Sample Size and Population  
The study is a randomized controlled trial with 50 participants, 25 per group. Participants 
will be pregnant women with SDB and major depressive disorder. Women will be 
randomly assigned to either PAP (PAP group) or treatment as usual (SDB group).  

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1. STUDY OBJECTIVES 
1.1 
Primary Objectives 
 Assess the impact of positive airway pressure (PAP) on depressive symptoms in women with 
prenatal sleep-disordered breathing (SDB) and depression. The PAP group, in comparison to the 
non-PAP group, will demonstrate improvements in depressive symptoms and more frequent 
remission of depression, as well as improved sleep quality, reduced sleep fragmentation, and 
increased sleep duration. 
   
Characterize the effect of PAP on the HPA axis in women with prenatal SDB and depression. 
Use of PAP will reduce levels of cortisol, a marker of HPA axis functioning, and reductions in 
cortisol will correlate with improvements in mood. 
 
1.2 
Secondary Objectives 
An additional, exploratory objective is to assess associations between PAP treatment and 
adverse pregnancy and neonatal outcomes. We hypothesize that the PAP group in comparison to 
the non-PAP group will show better delivery outcomes (lower rates of preterm birth, shorter 
hospitalization) and their infants will demonstrate greater neurodevelopment relative to those 
born to the non-PAP group. 
2. BACKGROUND AND RATIONALE 
2.1 
Background on Condition, Disease, or Other Primary Study Focus 
Sleep-disordered breathing (SDB) represents a spectrum of breathing disturbances during 
sleep, ranging from habitual snoring to obstructive sleep apnea. Between 3-17% of the 
population experiences SDB of at least moderate severity (Peppard et al., 2013). Consequences 
of SDB include cardiovascular and behavioral morbidity and mortality (T. Young et al., 2009). 
An estimated 9% of women of childbearing age have SDB; however, this figure is likely an 
underestimate, as 90% are undiagnosed (Peppard et al., 2013; T. Young et al., 1993). 
Furthermore, risk increases during pregnancy (Izci et al., 2006; Pien, Fife, Pack, Nkwuo, & 
Schwab, 2005). Published data, including our own, show that by the third trimester >30% of 
women demonstrate habitual snoring, the hallmark symptom of SDB (Bourjeily, Raker, 
Chalhoub, & Miller, 2010; Hutchison et al., 2012; O'Brien, Bullough, Owusu, et al., 2012). 
Perinatal depression affects nearly 20% of women (Gavin, 2005). Highly recurrent (Di 
Florio et al., 2013), severe cases can precipitate psychosis, suicide, and infanticide (Yonkers, 
2011). Despite the high prevalence, 50% of women with perinatal depression do not receive 
treatment (Ko, Farr, Dietz, & Robbins, 2012)and even with antidepressant treatment >40% 
remain depressed (Sit et al., 2011), conferring serious risk to themselves and their offspring. It is 
well-established that offspring born to depressed mothers as compared to healthy mothers have 
poorer proximal (e.g., shorter gestation, lower birth weight (Field et al., 2004)) and distal 
outcomes (e.g., childhood cognitive impairment (Hollins, 2007), self-regulation difficulties 
(Maughan, Cicchetti, Toth, & Rogosch, 2007)). A critical need exists for interventions that could 
improve these outcomes. 

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2.2 
Study Rationale 
Depression is a frequent morbidity of SDB. SDB of moderate severity increases the 
prospective risk for depression 2-fold, equivalent to the increase in risk for hypertension (T. 
Young et al., 2009). Estimates of the comorbidity between SDB and depression range from 18-
58% (Mosko et al., 1989; Ohayon, 2003). SDB is associated with treatment-resistant depression 
(Roest et al., 2012). Notably, treatment of SDB with positive airway pressure (PAP) significantly 
reduces depressive symptoms in patients with depression (El-Sherbini, 2011), including 
treatment-resistant depression (Habukawa et al., 2010).  
A new line of inquiry indicates that SDB is a risk factor for a variety of adverse 
pregnancy outcomes (Bourjeily et al., 2010; Facco et al., 2012; Louis et al., 2012; O'Brien, 
Bullough, Owusu, et al., 2012; O'Brien, Bullough, et al., 2013; Poyares et al., 2007). However, 
the relationship between SDB and perinatal depression, one of the leading causes of maternal 
morbidity (Colvin, Slack-Smith, Stanley, & Bower, 2013), is not well understood.   
Importantly, accumulating evidence now strongly indicates that maternal sleep 
disturbance is a key modifiable risk factor for depressive illness. Studies demonstrate that poor 
sleep quality (Dørheim, Bondevik, Eberhard-Gran, & Bjorvatn, 2009; Jomeen & Martin, 2007) 
and sleep fragmentation (Okun et al., 2011) are robustly associated with perinatal depressive 
symptoms. Poor sleep quality in early pregnancy directly predicts later depressive symptoms 
(Helen Skouteris, Germano, Wertheim, Paxton, & Milgrom, 2008; H. Skouteris, Wertheim, 
Germano, Paxton, & Milgrom, 2009). Furthermore, poor sleep quality in late pregnancy predicts 
postpartum depression (Okun et al., 2011; Wolfson, Crowley, Anwer, & Bassett, 2003). One of 
the most common, yet undiagnosed, causes of poor sleep quality is sleep disordered breathing 
(SDB). Notably, our own data show significant overlap between SDB and depressive symptoms 
in pregnancy; 43% of pregnant women who snore report significant depressive symptoms, 
relative to 23% of non-snorers (O'Brien, Owusu, & Swanson, 2013). Our findings, the first in a 
pregnant population, are consistent with other studies that show high comorbidity between SDB 
and depression. This raises the distinct possibility that treatment of SDB will improve perinatal 
depression. Importantly, PAP is a non-invasive, non-pharmacological intervention that can be 
readily implemented in pregnant women, as our own data demonstrate. However, the impact of 
SDB treatment on perinatal depression has not been investigated to date.     
Sleep fragmentation, a consequence of SDB, is associated with HPA axis hyperactivity 
(Follenius, Brandenberger, Bandesapt, Libert, & Ehrhart, 1992; Spath-Schwalbe, Gofferje, Kern, 
Born, & Fehm, 1991). Chronic activation of the HPA axis is a hypothesized pathway by which 
SDB may cause, and increase vulnerability to, depression. Hyperactivity of the axis is observed 
in both prenatal depression (Parcells, 2010; Rich-Edwards et al., 2008) and SDB (Vgontzas et 
al., 2007), and, importantly, predicts resistance to antidepressants (E. A. Young et al., 2004). The 
axis is normalized with PAP (Henley et al., 2009; Schmoller et al., 2009; Vgontzas et al., 2007). 
Maternal HPA axis functioning is implicated in fetal programming (Weinstock, 2005).  
PAP is the standard treatment for sleep-disordered breathing in the non-perinatal 
population. However, it has not been studied in pregnancy, and the effects of PAP treatment on 
SDB, health, and mental health in pregnant and postpartum women remains unknown. 
Participants will use PAP nightly through 12 weeks postpartum.  
Justification of Randomized Design 
We have proposed a randomized design – in which participants are assigned to either 
PAP therapy or treatment as usual -- only after careful consideration of ethical and safety issues, 

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and consultation with numerous leaders in the field. Conclusions from a panel discussion (held 
during the 2009 Annual Meeting of the Associated Professional Sleep Societies) regarding 
ethical issues in obstructive sleep apnea clinical trials were also utilized (Brown et al., 2011). Dr. 
Chervin, a co-investigator on this study, was a member of this panel, and he has conducted 
randomized, controlled trials in obstructive sleep apnea treatment. A randomized design was 
proposed for the study because in a non-randomized protocol many factors could influence 
acceptance or refusal of CPAP, and these confounding variables might obscure our ability to 
draw conclusions about effects of CPAP. 
We believe a randomized design is ethical based on several main points. First, there is a 
notable lack of published data and therefore significant clinical equipoise exists regarding the 
risks of SDB in pregnancy, the effects of PAP treatment in this population, and the ability of 
pregnant women to use PAP. The little evidence that does exist on risks of untreated SDB during 
pregnancy are conflicting. Importantly, there is no published evidence that treatment of SDB in 
pregnancy has any impact on maternal, obstetric, or neonatal outcomes. No guidelines have been 
published for treatment of SDB during pregnancy. Second, screening for SDB is not standard of 
care in pregnancy, and most pregnant women are never referred for sleep studies. Thus, the vast 
majority of pregnant women with SDB do not know they have this condition, and are untreated. 
Third, several large studies of SDB have assessed participants’ SDB status and followed them 
across many years without providing treatment, or randomizing participants to receive PAP or 
standard care (e.g., Sleep and Heart Health Study; Sleep Apnea cardioVascular Endpoint study). 
We also wish to reference a recent study of sleep apnea in pregnancy conducted by Facco and 
colleagues (Facco et al., 2014), wherein pregnant women were assessed for SDB and those 
diagnosed with SDB were not offered PAP treatment. Fourth, we have established a plan to 
protect participants from the most likely risk of untreated SDB, motor vehicle crash due to 
daytime sleepiness, further delineated in the Data Safety Monitoring Plan. This approach and the 
focus for safety purposes on sleepiness rather than other features of SDB follows published 
recommendations for SDB randomized trials (Brown et al. 2011). Finally, all participants will be 
offered referrals for SDB treatment upon conclusion of the study. In short, some individuals 
could benefit by participation in this trial; no participant will be prevented from seeking clinical 
care for SDB on their own accord; and participation in this research is not anticipated to impose 
incremental harm that would have been avoided absent participation.  
3. STUDY DESIGN 
This 5-year study is a randomized trial of PAP therapy in pregnant women with SDB and 
depression. The main objectives of the study are to (1) assess the impact of PAP on depression 
symptoms in women with prenatal SDB and depression and (2) characterize the effect of PAP on 
the HPA axis in women with prenatal SDB and depression. A secondary objective is to assess 
associations between PAP treatment and adverse pregnancy and neonatal outcomes.   
Fifty pregnant women who have comorbid SDB and depression will be enrolled in the study. 
Participants will be screened for depression using methodologies established by our group 
(Swanson, Flynn, Adams-Mundy, Armitage, & Arnedt, 2013). a Participants will be randomly 
assigned to PAP (n=25) or treatment as usual (n=25). Participants will complete assessments of 
sleep and mood at enrollment through 12 weeks postpartum.  
Participants will complete most aspects of the study in their home, including telephone-based 

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assessments. They will undergo an in-person eligibility interview, and complete an in-home 
sleep study to determine SDB   Those assigned to the PAP group will also complete their first 
night of PAP therapy in the sleep laboratory. Length of participation will vary depending on 
gestational age at enrollment and the length of each participant’s pregnancy. We anticipate that 
most women will participate for 4-6 months.  
Women who meet eligibility for the study will be randomized to either PAP or treatment as usual 
using the minimization method (Schulz, Altman, & Moher, 2010). In this CONSORT-approved 
method, the first participant is truly random, and thereafter participants are allocated to condition 
to minimize between-group imbalance of selected characteristics. Minimization is a viable 
alternative to true randomization, arguably superior as it allows for balanced groups even in 
smaller samples (Treasure & MacRae, 1998). We will balance assignment to group based on the 
following characteristics: race, gestation week, depression severity, SDB severity, 
socioeconomic status, partnered status, 1st trimester BMI. Participants will not be blind to 
condition. The study clinician, who will complete clinician-rated assessments of participants’ 
mood, will be blind to group assignment.    
Participants randomized to PAP treatment will be asked to use PAP nightly through 12 weeks 
postpartum. Participants will use PAP at home for the remainder of their pregnancy, through 12 
weeks postpartum.  
Participants randomized to the treatment as usual group will not be offered PAP, and will 
continue to receive care as usual within obstetrics (SDB group).  
 
4. SELECTION AND ENROLLMENT OF PARTICIPANTS  
Recruitment will occur through multiple sites at UM, leveraging the existing research 
infrastructure of the Women’s Mental Health and Infants Program (WMHIP). The WMHIP 
maintains an IRB-approved research recruitment registry at obstetrics clinics. Briefly, all women 
who present for care at the clinics complete a screen consisting of a demographic form, perinatal 
depression measure (EPDS), a question regarding habitual snoring, and consent to be contacted 
for research. A research assistant inspects all forms for study eligibility and eligible women are 
contacted.  
Other sources of recruitment include the Women and Infants Mental Health Clinic at UMHS, 
UMClinicalstudies.org website, and fliers posted in the community and UMHS clinics.  
Subjects may be identified from the M-STRIDES database - the clinical database of the 
Department of Psychiatry, based on their Edinburgh Postnatal Depression Scale score. They may 
also be identified from the UMHS Obstetrics Clinic appointment list; those patients who have 
documentation of depression or an Edinburgh Postnatal Depression Scale score ≥8 in their 
medical record may be contacted. Finally, we may also use Emerse to identify potential 
participants across UMHS. For these recruitment sources, we will send participants a letter to 
introduce the study, including information for how to opt out of follow-up contact regarding the 
study. Participants who do not opt out of contact may be contacted by telephone or email to 
discuss their interest in the study.   
 

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4.1 
Inclusion Criteria 
Females 18-45 years and: (1) 20-32 weeks gestation with a single, live fetus, (2) meet criteria for 
major depressive disorder per the Structured Clinical Interview for DSM-V (SCID), (3) apnea 
symptoms (snoring, witnessed apnea, daytime sleepiness, sleep disturbance, snort arousals), (4) 
and if taking an antidepressant, dose must be stable (for ≥8 weeks); if not using an antidepressant 
medication, participant must be free of all antidepressants for the past 4 weeks.  
4.2 
Exclusion Criteria 
(1) Diagnosis of bipolar disorder, posttraumatic stress disorder, schizophrenia or psychosis, 
dissociative disorders, eating disorder, obsessive-compulsive disorder, somatic symptom and 
related disorders, substance use disorder, panic disorder, agoraphobia per DSM-V, (2) diagnosis 
of, or suspicion for, narcolepsy or REM behavior disorder, (3) current SDB treatment, (4) 
medical conditions for which PAP is contraindicated (e.g., pneumothorax, pneumocephalus, 
recent trauma, recent surgery), and (5) evidence of risk for drowsy driving (excessive daytime 
sleepiness plus history of motor vehicle accident or near miss due to sleepiness, fatigue, or 
inattention in past 12 months).  
4.3 
Study Enrollment Procedures  
Potential participants identified from the research recruitment registry will be contacted and 
those who agree to participate will be invited to complete an interview to assess eligibility. All 
participants will complete written informed consent before they complete the eligibility 
interview. The eligibility interview will consist of self-report and clinician rated measures of 
mood and sleep, the SCID, Hamilton Rating Scale for Depression (HRSD), and Pittsburgh Sleep 
Quality Index (PSQI), as well as information regarding demographics.. A study Screening Log 
will be maintained to document reasons for ineligibility and reasons for declined participation in 
eligible participants.   
5. STUDY INTERVENTIONS  
5.1 
Interventions, Administration, and Duration  
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. The initial trial night of 
PAP will be conducted in a monitored, technologist-attended sleep laboratory. Heated 
humidification will be used in this study, to minimize nasal symptoms and optimize adherence. 
The auto-titrating PAP delivers a minimum effective pressure with the result that the mean 
pressure over the course of the night is often lower than the fixed pressure delivered by 
continuous PAP, and therefore tolerance of PAP may be improved. This device is ideal for 
pregnant women, as it automatically adjusts pressure settings to optimally treat SDB by adapting 
to the fluctuations in weight and edema typically experienced through pregnancy and into 
postpartum without additional laboratory visits for re-titration. As in our other protocols of PAP 
in pregnancy, participants will receive the first night of therapy in the sleep laboratory. Treating 
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be informed if any issues arise with use of PAP.  Subjects will have almost daily contact initially 
with the research team, which typically tapers to a weekly telephone call to discuss any problems 
or questions. This greatly exceeds generally available standard of care, but is successfully used in 
our pregnancy protocols and will optimize safety and yet remain generalizable to clinical settings 
where high-risk obstetric clinic personnel probably could replicate these frequent contacts, in 
person or by phone, when necessary.  Women will use the PAP device for the remainder of their 
pregnancy and through 12 weeks postpartum. In comparison, people in the general population 
who use PAP for SDB often use it for many years. 
Risks of PAP therapy are minor, typically discomfort as the participant adjusts to PAP 
therapy, and other minor risks related to mask problems or nasal symptoms. There is a rare risk 
of pneumothorax or pneumocephalus. All documented events of pneumothorax or 
pneumocephalus occurred in women who had previous trauma and/or nasal surgery. Therefore, 
participants with recent head trauma or surgery (pituitary or nasal) that may have produced 
cranio-nasopharyngeal fistula (risk of entry of air or other material into the cranial cavity) will be 
excluded from the study. The most frequent risks, all minor, and interventions to minimize these 
risks are as follows: 
 
Mask problem: 
Air leaks 
 
 
Proper mask fitting and application 
Skin irritation 
Avoid over tightening of headgear; use of nasal pillows 
Mouth dryness 
 
Chin strap to eliminate mouth leak; heated humidity 
Mask claustrophobia  
Nasal pillows-type of interface 
 
Nasal symptoms: 
Congestion 
                        Chin strap; heated humidity; nasal saline 
Nose bleed 
                        Chin strap; heated humidification; nasal saline rinses 
Rhinitis 
                        Nasal saline rinses 
 
Treatment as Usual  
In this condition, participants will continue their care through obstetrics. Positive airway 
pressure therapy is not provided as part of usual care in obstetrics.   
5.2 
Concomitant Interventions  
 
The clinical care of participants will not be altered or affected in any way by their 
participation in the study. No interventions will be prohibited. Use of medications, including 
those for depression (eg, SSRIs), and other depression treatments (eg, psychotherapy), will be 
monitored and documented throughout the study, but participants will not be prevented or 
prohibited from accessing such care, or in making changes to their medications or clinical care.  
5.3 
Adherence Assessment  
Use of PAP will be monitored using web-based software, which will provide real-time, web-
based notification of nightly use. Adherence is defined as four hours or more of PAP use on 70% 
or more of nights. Participants who use PAP for <4 hours will be contacted the same day by 
telephone to address barriers to use and enhance motivation. Early intervention is crucial to 
maximize adherence (Budhiraja et al., 2007). 

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6. STUDY PROCEDURES  
6.1 
Schedule of Evaluations 
Assessment 
Screening
: 
Eligibility 
interview 
In-lab 
PAP trial 
(PAP 
group) 
Baseline Week 
1 
Monthly 
through 
pregnancy 
 
Week 
8 
After 
delivery 
Postpartum 
follow-up 1 
(Month 1) 
Postpartum 
follow-up 2 
(Month 2) 
Final Visit 
(12 weeks 
postpartum) 
Informed Consent Form   
X 
 
 
 
 
 
 
 
 
 
Demographics,  medical history, & ACE 
X 
 
 
 
 
 
 
 
 
 
Inclusion/Exclusion Criteria 
X 
 
 
 
 
 
 
 
 
 
In-home sleep monitoring 
 
 
X 
 
 
 
 
 
 
X 
In-lab PAP therapy night 
 
X 
 
 
 
 
 
 
 
 
Blood draw 
 
 
X 
 
 
X 
 
 
 
 
Depression measures (HRSD, EPDS, C-SSRS) 
 
 
X 
X 
X 
X 
 
X 
X 
X 
Sleep measures (PSQI, ISI, ESS) 
 
 
X 
X 
X 
X 
 
X 
X 
X 
Relationship measures (RQS; PBI or MFA) 
 
 
X 
 
 
 
 
 
 
X 
Cortisol (saliva collection) 
 
 
X 
 
 
X 
 
 
 
 
Sleep diary 
 
 
X 
 
 
X 
 
 
 
 
Actigraphy and SF12 
 
 
X 
 
 
X 
 
 
 
X 
Medical record abstraction (pregnancy & 
infant) 
 
 
 
 
 
 
X 
 
 
 
Neonatal development assessment 
 
 
 
 
 
 
X 
 
 
 
Ages and Stages Questionnaire-3  
 
 
 
 
 
 
 
 
 
X 
Adverse Events  
X 
X 
X 
X 
X 
X 
X 
X 
X 
X 

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6.2 
Description of Evaluations  
6.2.1 Screening Evaluation 
Consenting Procedure 
A waiver of consent is sought to allow access to potential participants’ medical 
records prior to the eligibility interview to determine initial eligibility based on 
pregnancy status, current health, medical history, and medications.    
Written informed consent will be obtained prior to the eligibility interview. Informed 
consent will be conducted by the PI or study coordinator. The informed consent 
document will be reviewed in detail with the potential participant, and any questions 
will be answered. A hard copy of the signed informed consent document will be 
maintained in the study’s records, which will be stored in a locked cabinet in a locked 
office accessible only by study staff. 
Screening 
An initial screen will occur prior to the full eligibility interview. This screen will 
involve examination of potential participants’ medical records and a telephone screen 
to determine preliminary eligibility.  
The full eligibility interview includes 
 Structured Clinical Interview for DSM-V (SCID) 
o Standardized, structured clinical interview to obtain information 
regarding current and past mental health history necessary to for 
diagnosis. Diagnostic criteria are based on the DSM-V.  Information to 
be obtained includes mental health symptoms, frequency, and duration 
of symptoms of mood disorders, anxiety disorders, substance use 
disorders, eating disorders, and psychosis.   
 Columbia-Suicide Severity Rating Scale (C-SSRS) 
o Structured clinician-administered interview to obtain information 
regarding risk for suicide.  
 Medical history  
o Participants will complete a questionnaire indicating their history of 
medical conditions. They will also list their current medications.  
o Corroborating information will also be abstracted from participants’ 
medical records.  
 Sleep  
o Participants will complete questionnaires to assess their sleep patterns 
and to determine risk for sleep disorders. Questionnaires will include 
the Stop-Bang for SDB symptoms and questions about RLS 
symptoms. They will also complete a questionnaire (the Pregnancy 

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and Sleep Questionnaire) to characterize their sleep before and during 
pregnancy.  
 
  6.2.2 
Enrollment, Baseline, and/or Randomization 
Enrollment 
 
Participants who meet study criteria based on the eligibility interview will be 
enrolled in the study. They will be randomized to condition at the time of enrollment.  
Baseline Assessments 
 In-home overnight sleep monitoring (Watch-PAT) 
o Baseline sleep and sleep-disordered breathing characteristics will be 
assessed in participants’ homes. Participants will wear a watch-like 
device worn on the wrist (Watch-PAT) will measure sleep/wake times 
and blood volume changes (monitored via sensor worn on the finger).    
 Participants randomized to the PAP group will complete a pre/post sleep 
questionnaire the night they sleep in the lab. 
 Hamilton Rating Scale for Depression (HRSD) 
o The HRSD is a clinician-rated assessment of depression symptoms.   
 Edinburgh Postnatal Depression Scale (EPDS) 
o The EPDS is a self-report scale of perinatal depression symptoms.  
 Relationship Quality Scale (RQS) 
o The RQS is a measure of relationship quality, and assesses several 
different relationship domains, including love, conflict, and 
ambivalence.   
 Maternal-Fetal Attachment Scale (MFA) 
o The MFA is a measure of maternal attachment during pregnancy. It 
yields several subscales, including giving of self, differentiation of self 
from fetus, role taking, nesting, attributing characteristics to the fetus, 
and interaction with the fetus.  
 Pittsburgh Sleep Quality Index (PSQI) 
o The PSQI is a self-report scale of sleep quality. It assesses 7 domains 
of sleep (duration, sleep disturbance, sleep latency, daytime 
dysfunction, sleep efficiency, sleep quality, medication use), in 
addition to a global sleep quality score.  
 Insomnia Severity Index (ISI) 
o The ISI is a self-report measure of insomnia symptoms.  
 Epworth Sleepiness Scale (ESS) 
o The ESS measures daytime sleepiness to assess for excessive daytime 
sleepiness.  
 ACE – Adverse Childhood Experience Questionnaire 
o This questionnaire assesses history of adverse childhood experiences. 

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 SF12 
o This questionnaire measures functioning and functional impairment.  
 Actigraphy 
o Sleep-wake and activity patterns will be measured using wrist 
actigraphy. Wrist actigraphy data are collected using a wrist-worn, 
watch-like device that measures light and motion.  
 Daily sleep diary 
o Participants will complete approximately one week of daily sleep 
diaries at baseline. The diary will collect information regarding self-
reported bed and wake times, sleep onset latency, wake after sleep 
onset, frequency of nighttime awakenings, and sleep quality. 
Information regarding daytime behaviors which may affect sleep, such 
as napping and caffeine use, will also be collected.    
 Blood draw 
 Cortisol 
o Salivary cortisol will be assessed in participants’ homes. They will be 
provided with a salivary cortisol collection kit. They will use the kit to 
collect saliva by chewing on a salivette upon awakening, 30-45 
minutes after awakening, in the afternoon (3-4 pm), and within 45 
minutes before bedtime on 3 consecutive days. The kit will include an 
alarm system that will alert them to each saliva sample collection time. 
Participants will also complete a measure of daily hassles (The Hassles 
and Uplifts Scale) on each day of saliva collection.  
 
6.2.3 Blinding 
 
The study clinician will be responsible for completing the clinician rated study 
assessments with participants. The study clinician will be blind to participant condition. 
Participants will be reminded at the outset of each assessment that the study clinician is blind to 
their group assignment, and ask them to not reveal any information which may indicate their 
group.   
 
6.2.4 Follow-up Visits 
The first follow-up visit will occur roughly 1 week after study enrollment. Subsequent follow-up 
visits will occur at roughly monthly intervals thereafter through approximately 12 weeks 
postpartum. The HRSD and C-SSRS will be administered via telephone by the study clinician. 
The remaining measures will be completed by the participant by internet; in cases where 
participants do not have internet access, the measures may also be completed by mail.    
  
Follow-up visits will include the following measures: 
 
 Hamilton Rating Scale for Depression (HRSD) 
o The HRSD is a clinician-rated assessment of depression symptoms.  
 Columbia-Suicide Severity Rating Scale (C-SSRS) 
o Structured clinician-administered interview to obtain information 

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regarding risk for suicide.  
 Edinburgh Postnatal Depression Scale (EPDS) 
o The EPDS is a self-report scale of perinatal depression symptoms.  
 Pittsburgh Sleep Quality Index (PSQI) 
o The PSQI is a self-report scale of sleep quality. It assesses 7 domains 
of sleep (duration, sleep disturbance, sleep latency, daytime 
dysfunction, sleep efficiency, sleep quality, medication use), in 
addition to a global sleep quality score.  
 Epworth Sleepiness Scale (ESS) 
o The ESS is a self-report measure of excessive daytime sleepiness.  
 Insomnia Severity Index (ISI) 
o The ISI is a self-report measure of insomnia symptoms.  
 Driving questions 
o To assess safety, participants will be asked if they have experienced 
any motor vehicle accidents or near-misses since the last assessment. 
Participants who report such an event will be further queried regarding 
the circumstances of the event to determine whether drowsiness or 
inattention was a factor.  
 Current medications 
 Breastfeeding 
o After a participants delivers their baby, we will ask them if they are 
breastfeeding. 
 
The follow-up visit conducted around week 8 of the study, approximately two months after 
enrollment(conducted between 6-9 weeks after enrollment), will also include these additional 
measures:  
 Actigraphy 
o Sleep-wake and activity patterns will be measured using wrist 
actigraphy. Wrist actigraphy data are collected using a wrist-worn, 
watch-like device that measures light and motion.  
 Daily sleep diary 
o Participants will complete approximately one week of daily sleep 
diaries at baseline. The diary will collect information regarding self-
reported bed and wake times, sleep onset latency, wake after sleep 
onset, frequency of nighttime awakenings, and sleep quality. 
Information regarding daytime behaviors which may affect sleep, such 
as napping and caffeine use, will also be collected.    
 SF12 Questionnaire 
 Blood draw 
 Cortisol 
o Salivary cortisol will be assessed in participants’ homes. They will be 
provided with a salivary cortisol collection kit. They will use the kit to 
collect saliva by chewing on a salivette upon awakening, 30-45 
minutes after awakening, in the afternoon (3-4 pm), and within 45 
minutes before bedtime on 3 consecutive days. The kit will include an 

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alarm system that will alert them to each saliva sample collection time. 
Participants will also complete a measure of daily hassles (The Hassles 
and Uplifts Scale) on each day of saliva collection.  
 
Prior to hospital discharge following birth, participants’ infants will complete a non-invasive, 
simple assessment focused on the infant’s neurodevelopment. Following delivery, medical 
records of the participant and their infant will also be accessed to abstract data regarding their 
health; specific information to be obtained from the participant’s record includes delivery type 
(e.g., operative or vaginal), gestational length, birth complications, and days of hospitalization. 
Information to be obtained from the medical record of the participant’s infant include length, 
gender, weight, head circumference, transfer to NICU, length of hospital stay.  
 
We will send the participant a congratulations card after the baby has been born.  
6.2.5 Completion/Final Evaluation 
At the final evaluation, the following measures will be completed:  
 Hamilton Rating Scale for Depression (HRSD) 
o The HRSD is a validated clinician-rated assessment of depression 
symptoms.  
 Edinburgh Postnatal Depression Scale (EPDS) 
o The EPDS is a validated self-report scale of perinatal depression 
symptoms.  
 Brockington Postpartum Bonding Instrument (PBI) 
o The PBI is a validated self-report measure of parent-infant bonding 
and attachment.  
 Pittsburgh Sleep Quality Index (PSQI) 
o The PSQI is a validated self-report scale of sleep quality. It assesses 7 
domains of sleep (duration, sleep disturbance, sleep latency, daytime 
dysfunction, sleep efficiency, sleep quality, medication use), in 
addition to a global sleep quality score.  
 Insomnia Severity Index (ISI) 
o The ISI is a self-report measure of insomnia symptoms.  
 Epworth Sleepiness Scale (ESS) 
o The ESS is a validated, self-report measure of excessive daytime 
sleepiness.  
 SF12 Questionnaire 
 Current medications and medical history 
 Ages and Stages Questionnaire-3 (ASQ-3) 
o The ASQ-3 is a valid, brief, parent-rated measure of infant 
development. The measure assesses communication, gross motor, fine 
motor, problem-solving, and adaptive skills.  
 Wear the Watch-PAT device one night at home. 
 Actigraphy 

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o Sleep-wake and activity patterns will be measured using wrist 
actigraphy. Wrist actigraphy data are collected using a wrist-worn, 
watch-like device that measures light and motion.  
 Daily sleep diary 
o Participants will complete approximately one week of daily sleep 
diaries at baseline. The diary will collect information regarding self-
reported bed and wake times, sleep onset latency, wake after sleep 
onset, frequency of nighttime awakenings, and sleep quality. 
Information regarding daytime behaviors which may affect sleep, such 
as napping and caffeine use, will also be collected.    
 Infant’s medical history 
o Information regarding the infant’s medical history, including any 
hospitalizations.  If they have been hospitalized we will get the reason 
why.  
 
 
Participants will be offered referrals for clinical care for both depression and sleep-disordered 
breathing upon completion of the study.  
7. STATISTICAL CONSIDERATIONS  
7.1 
Data Analyses  
Data analysis plan for objective 1: 
Linear mixed models using a repeated measures group X time (weeks of study) will be used to 
assess main effects and interactions for intervention and treatment week on HRSD, EPDS, PSQI,   
ESS scores. Logistic regression will assess for the odds of remission by treatment group. 
Covariates to be included in the models proposed in the analysis include maternal age, marital 
relationship quality, bonding, pregnancy and delivery complications, and SSRI dosage. Should 
other demographic characteristics differ between groups despite the minimization assignment 
method, these will be included as covariates. 
 
Data analysis plan for objective 2:  
Cortisol values for each time point will be averaged across the 3-day period to obtain an average 
for pre and post-treatment assessments. Linear mixed models using a repeated measures group X 
time (weeks of study) will be used to assess main effects and interactions for intervention and 
treatment week on cortisol. Correlations will assess the relationship between change in 
depression scores (HRSD, EPDS) and cortisol. Covariates to be included in the models include 
gestational week at assessment, marital relationship quality, BMI, and pregnancy and delivery 
complications.   
 
Data analysis for secondary objective: 
The effects of treatment group on gestational age at delivery, type of delivery, length of 
hospitalization, and neurodevelopmental score will be conducted using linear regression. 
Logistic regression, covaried for gestational age, will assess for the odds of failing domains on 
the ASQ-3 by treatment group. Covariates may include maternal education, baseline EPDS 
score, SSRI dose, bonding, and maternal health. 

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8. DATA SAFETY MONITORING BOARD  
A Data Safety Monitoring Board has been established for the study. The DSMB is responsible 
for safeguarding the interests of study participants, assessing the safety and efficacy of study 
procedures, and for monitoring the overall conduct of the study. Please see the DSMB’s charter 
and Data Safety Monitoring Plan for more detail.   
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