Sleep-disordered BreathingNCT02507297

Sleep-Disordered Breathing and PAP in Perinatal Depression

A study testing Positive Airway Pressure (PAP) in people with Sleep-disordered Breathing and Major Depressive Disorder, run by University of Michigan at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Sleep-disordered Breathing, Major Depressive Disorder
What is being tested?: Positive Airway Pressure (PAP)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited States
Study dates: Jan 2016to 25 Apr 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

20-32 weeks gestation with a single, live fetus
meet criteria for major depressive disorder per the Structured Clinical Interview for DSM-V (SCID)
respiratory distress index (RDI; includes apneas, hypopneas, and respiratory effort-related arousals)≥5 per ambulatory assessment plus apnea symptoms (snoring, witnessed apnea, daytime sleepiness, sleep disturbance, snort arousals)
stable dose (for ≥8 weeks) of a selective serotonin reuptake inhibitor (SSRI) OR free of all antidepressant medications past 4 weeks
obstetrics care is at the University of Michigan, and the woman plans on delivering her baby at the University of Michigan

Who cannot join

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
diagnosis of, or suspicion for, narcolepsy or REM behavior disorder
current SDB treatment; medical conditions for which PAP is contraindicated (e.g., pneumothorax, pneumocephalus, recent trauma, recent surgery)
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).

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Michigan
Ann Arbor, Michigan, 48109

Other trials in United States

About this study

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.

Conditions: Sleep-disordered Breathing, Major Depressive Disorder
Being tested: Positive Airway Pressure (PAP)
Medical subject headings: Sleep Apnea Syndromes, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Positive Airway Pressure (PAP)Device
Also called CPAP
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.

Study groups in NCT02507297
Study group	Role	What they receive
PAP Group	Experimental	Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly Receives: Device: Positive Airway Pressure (PAP)
TAU Group	No intervention	Treatment as usual through obstetrics

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (4)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 201625 Apr 2020

First posted23 Jul 2015 (estimated)
Study startJan 2016
Primary completion25 Apr 2020
Study completion25 Apr 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Sleep-disordered BreathingStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02507297
Sponsor's protocol ID: 1K23HL122461-01A1
Status last verified: Apr 2023
First submitted: 22 Jul 2015
Last updated: 1 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Sleep-disordered Breathing trials

Study at a glance

From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Sleep-Disordered Breathing and PAP in Perinatal Depression
ClinicalTrials.gov ID: NCT02507297
Acronym / sponsor ID: 1K23HL122461-01A1
Conditions: Sleep-disordered Breathing, Major Depressive Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: Jan 2016 (actual)
Primary completion: 25 Apr 2020 (actual)
Study completion: 25 Apr 2020 (actual)
First posted: 23 Jul 2015 (estimated)
Results: Posted 13 May 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
PAP Group	Experimental	Device: Positive Airway Pressure (PAP)Positive airway pressure (PAP) delivered through an auto-titrating machine, to be used nightly
TAU Group	No intervention	–Treatment as usual through obstetrics

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

20-32 weeks gestation with a single, live fetus
meet criteria for major depressive disorder per the Structured Clinical Interview for DSM-V (SCID)
respiratory distress index (RDI; includes apneas, hypopneas, and respiratory effort-related arousals)≥5 per ambulatory assessment plus apnea symptoms (snoring, witnessed apnea, daytime sleepiness, sleep disturbance, snort arousals)
stable dose (for ≥8 weeks) of a selective serotonin reuptake inhibitor (SSRI) OR free of all antidepressant medications past 4 weeks
obstetrics care is at the University of Michigan, and the woman plans on delivering her baby at the University of Michigan

Key exclusion criteria (4 listed)

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
diagnosis of, or suspicion for, narcolepsy or REM behavior disorder
current SDB treatment; medical conditions for which PAP is contraindicated (e.g., pneumothorax, pneumocephalus, recent trauma, recent surgery)
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Positive Airway Pressure (PAP)Also: CPAPPositive 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.	Device	PAP Group

Primary outcome

Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item
Time frame: Baseline to 8 weeks after baseline, and at 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.

4 secondary outcomes

Change in Edinburgh Postnatal Depression Scale Score
Time frame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum
Change in Pittsburgh Sleep Quality Index Score
Time frame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum
Change in Epworth Sleepiness Scale (ESS) Score
Time frame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum
Change in Salivary Cortisol
Time frame: Baseline to 8 weeks after baseline

Results and safety

Results posted to the registry on 13 May 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PAP Group	16	15
TAU Group	13	12

Primary outcome: Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item

Time frame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum. Mean (Standard Deviation). Unit: change in score

Measure	PAP Group n = 13	TAU Group n = 13
Baseline to 8 weeks after baseline	-7.62 (5.65)	-5.92 (3.47)
Baseline to 12 weeks postpartum	-8.21 (7.39)	-6.18 (6.51)

PAP Group vs TAU Group: p = .367, t-test, 2 sided
PAP Group vs TAU Group: p = .48, t-test, 2 sided

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from randomization until participants reached 12 weeks postpartum (the final time point in the study).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
PAP Group	3 of 16 (18.8%)	10 of 16 (62.5%)	0 of 16
TAU Group	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Sleep-disordered Breathing

Not yet recruitingObservational study
Registry of Central Sleep Apnea Patients Undergoing remedē System Implant
Central Sleep Apnea (Diagnosis), Central Sleep Apnea Syndrome
Active, not recruitingObservational study
Sleep Quality in Patients With Non-cystic Fibrosis Bronchiectasis
Bronchiectasis, Sleep-Disordered Breathing
Active, not recruitingObservational study
Epidemiology of Sleep-Disordered Breathing in Adults
Sleep Disorders, Cerebrovascular Disorders
RecruitingObservational study
Respiratory Progression in Adults With Duchenne Muscular Dystrophy.
Duchenne Muscular Dystrophy (DMD), Respiratory Function Decline
RecruitingPhase 4
Central Apnea in Heart Failure: Physiological Mechanisms to Inform Treatment
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Leslie Swanson, Ph.D. principal investigator

University of Michigan

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Positive Airway Pressure (PAP) in people with Sleep-disordered Breathing and Major Depressive Disorder, run by University of Michigan at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hamilton Rating Scale for Depression (HRSD) Score, Minus the Sleep Item (time frame: Baseline to 8 weeks after baseline, and at 12 weeks postpartum). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02507297.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.