Sleep Disordered BreathingNCT02330055

Determination of the Predictors of Nocturnal Desaturation in Postpartum Women

A study testing Forty-five degrees elevated upper body position, non-elevated upper body position and Noninvasive wrist pulse oximeter (WristOx Model 3150) in people with Sleep Disordered Breathing and Nocturnal Oxygen Desaturation, run by Massachusetts General Hospital 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 55 years, women only
Conditions the study is for: Sleep Disordered Breathing, Nocturnal Oxygen Desaturation, Upper Airway Edema
What is being tested?: Forty-five degrees elevated upper body position, non-elevated upper body position and Noninvasive wrist pulse oximeter (WristOx Model 3150)
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 99 participants
Where: 1 siteUnited States
Study dates: May 2014to Dec 2017
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 55 years
Women only
No healthy volunteers
Adult

Who may be able to join

Postpartum mothers within 24 hours of delivery
Age over 18 years.
Admitted to the Massachusetts General Hospital OB service for the delivery.
Interventions will be randomly assigned to the patients enrolled in this study

Who cannot join

1 Age under 18 years

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

The primary aim of the study is to evaluate the effect of the method of delivery (vaginal delivery vs. cesarean section) on oxygen saturation in the first postpartum night. The investigators hypothesize that nocturnal desaturation occurs more frequently in cesarean section compared with vaginal delivery, expressed as either the duration of SpO2 below 90% or the Oxygen Desaturation Index (ODI). The ODI is defined as number of oxygen desaturations by at least 3 % per hour. Furthermore, the investigators expect a higher pulse rate and a lower mean and minimum SpO2 in the cesarean section group compared with the vaginal delivery group.

The secondary aim of the study is to investigate how the upper body position during sleep (45 degree elevated vs. non-elevated) affects the oxygen saturation during the first postpartum night.

The investigators hypothesize that an upper body elevation to 45 degrees decreases the incidence of desaturation events, expressed as either the duration of SpO2 below 90% or the ODI , compared with a non-elevated body position within each delivery group (vaginal delivery or cesarean section).

The third aim of the study is to identify independent predictors of nocturnal desaturation in postpartum women. To that end, the investigators will administer questionnaires and collect demographic and clinical data according to various obstructive sleep apnea screening scores, including the P-SAP, STOP-Bang, and Epworth Sleepiness Scale. The investigators will also ask the patient to rate the pain during the study night on a verbal numerical rating scale.

Read the detailed description

Sleep-disordered breathing is common in pregnancy, persisting into the early postpartum period. Postpartum airway obstruction is a main cause of anesthesia-related maternal death in North America. Upper airway edema following labor and delivery may impair pharyngeal anatomy, which can lead to increased vulnerability of the airway collapse during sleep.

This study evaluates whether the kind of delivery (vaginal birth versus cesarean section) has an effect on nocturnal desaturation in the first night after delivery. Furthermore, the investigators examine if the upper body position during sleep has an effect on the occurrence of oxygen desaturation.

In addition, the investigators evaluate if preexisting conditions, as indicated by a high P-SAP or STOP-Bang-score increase the likelihood of nocturnal desaturation.

Conditions: Sleep Disordered Breathing, Nocturnal Oxygen Desaturation, Upper Airway Edema
Being tested: Forty-five degrees elevated upper body position, non-elevated upper body position, Noninvasive wrist pulse oximeter (WristOx Model 3150), Stop-Bang questionnaire, Epworth Sleepiness Scale
Medical subject headings: Sleep Apnea Syndromes

What participants receive

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

Forty-five degrees elevated upper body positionProcedure or surgery
non-elevated upper body positionProcedure or surgery
Noninvasive wrist pulse oximeter (WristOx Model 3150)Device
The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
Stop-Bang questionnaireOther
The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire includes snoring, tiredness, observed apneas, blood pressure, Body Mass Index, age, neck circumference and gender.
The investigators will ask the patient to answer the questionnaire and measure the neck circumference.
Epworth Sleepiness ScaleOther
The Epworth Sleepiness Scale is a well-established clinical tool to quantify daytime sleepiness. It is clinically used for the diagnosis of sleep disorders.
The investigators will ask the patient to complete the questionnaire and will specify that the questionnaire pertains to the patient's pre-admission condition.
P-SAP ScoreOther
The P-SAP Score is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
The investigators will ask the patient to answer the questionnaire and will assess the Mallampati Score. The investigators will also measure the neck circumference and the Thyromental distance.
self-reported painOther
A verbal numerical rating scale is used to asses the pain during the study-night.

Study groups in NCT02330055
Study group	Role	What they receive
Forty-five degrees elevated upper body position	Active comparator	If the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events. The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain. Receives: Procedure: Forty-five degrees elevated upper body position; Device: Noninvasive wrist pulse oximeter (WristOx Model 3150); Other: Stop-Bang questionnaire; Other: Epworth Sleepiness Scale; Other: P-SAP Score; Other: self-reported pain
Non-elevated upper body position	Placebo comparator	If the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events. The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain. Receives: Procedure: non-elevated upper body position; Device: Noninvasive wrist pulse oximeter (WristOx Model 3150); Other: Stop-Bang questionnaire; Other: Epworth Sleepiness Scale; Other: P-SAP Score; Other: self-reported pain

What is being measured

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

SpO2 < 90%
Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery
Measured: 48 hours after delivery

Secondary outcomes (6)

Oxygen Desaturation Index > 3
ODI (oxygen desaturation index), assessed by pulse oximetry during the first night after delivery. ODI is defined as number of desaturation events per hour; a desaturation event is defined as drop in SpO2 of 3% or more from baseline SpO2. Baseline SpO2 is defined as the mean SpO2 of the SpO2 values taken over the preceding 120 seconds.
Measured: 48 hours after delivery
Minimal & Mean SpO2
Basic pulseoximetry in the first night after delivery
Measured: 48 hours after delivery
P-SAP Score
A Perioperative sleep apnea prediction (P-SAP) Score. This score ranges from 0 to 69, 0 representing low risk of obstructive sleep apnea and 69 representing high risk of obstructive sleep apnea.
Measured: 48 hours after delivery
STOP-BANG Score
The STOP BANG (This abbreviation consists of the first letter of each question in the questionnaire. S-Snore, T-Tired, O-Observed stop in breathing, P-High blood pressure, B-BMI, A - Age, N-Neck circumference, G-Gender. This questionnaire is a proven tool that can be used to screen for obstructive sleep apnea (OSA). This tool will assess if you are low, moderate or high risk group for sleep apnea. Scores range from 0-8. 0 indicates low risk for sleep apnea, 8 indicates high risk for sleep apnea.
Measured: 48 hours after delivery
Pain-score on a Verbal Numerical Rating Scale
Assessment of intensity of acute pain. Measured from 0-10, 0 being no pain and 10 being highest level of pain.
Measured: 48 hours after delivery
Average Pulse Rate
As measured in beats per minute
Measured: 48 Hours after delivery

Timeline

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

May 2014Dec 2017

First posted1 Jan 2015 (estimated)
Study startMay 2014
Primary completionFeb 2017
Study completionDec 2017

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 Massachusetts General HospitalThe 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: None (open label)
Enrolment: 99 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02330055
Sponsor's protocol ID: 2011P001326B
Status last verified: Jun 2018
First submitted: 23 Dec 2014
Last updated: 6 Jul 2018
Results posted: Yes, on ClinicalTrials.gov

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 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Determination of the Predictors of Nocturnal Desaturation in Postpartum Women
ClinicalTrials.gov ID: NCT02330055
Acronym / sponsor ID: 2011P001326B
Conditions: Sleep Disordered Breathing, Nocturnal Oxygen Desaturation, Upper Airway Edema
Study type: Interventional
Recruitment status: Completed
Enrolment: 99 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: May 2014
Primary completion: Feb 2017 (actual)
Study completion: Dec 2017 (actual)
First posted: 1 Jan 2015 (estimated)
Results: Posted 9 Apr 2018

Clinical summary

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

The secondary aim of the study is to investigate how the upper body position during sleep (45 degree elevated vs. non-elevated) affects the oxygen saturation during the first postpartum night.

Detailed description

In addition, the investigators evaluate if preexisting conditions, as indicated by a high P-SAP or STOP-Bang-score increase the likelihood of nocturnal desaturation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Forty-five degrees elevated upper body position	Active comparator	Procedure: Forty-five degrees elevated upper body position, Device: Noninvasive wrist pulse oximeter (WristOx Model 3150), Other: Stop-Bang questionnaire, Other: Epworth Sleepiness Scale, Other: P-SAP Score, Other: self-reported painIf the patient is randomized in this study arm after enrollment, the investigators will elevate the patients upper body to 45 degree prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events. The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.
Non-elevated upper body position	Placebo comparator	Procedure: non-elevated upper body position, Device: Noninvasive wrist pulse oximeter (WristOx Model 3150), Other: Stop-Bang questionnaire, Other: Epworth Sleepiness Scale, Other: P-SAP Score, Other: self-reported painIf the patient is randomized in this study arm after enrollment, the investigators will flatten the patients upper body to a supine position prior to sleeping. The patient will wear a pulseoximeter (WristOx Model 3150) during the night. The investigators will collect the SpO2 and pulse rate with this device and then quantify desaturation events. The investigators will ask the patient to fill out a questionnaire, which includes the P-SAP score, the STOP-BANG score, the Epworth Sleepiness Scale and the self-reported pain.

Who may qualify

Ages: 18 to 55 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Postpartum mothers within 24 hours of delivery
Age over 18 years.
Admitted to the Massachusetts General Hospital OB service for the delivery.
Interventions will be randomly assigned to the patients enrolled in this study

Key exclusion criteria (1 listed)

1 Age under 18 years

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
Forty-five degrees elevated upper body position	Procedure or surgery	Forty-five degrees elevated upper body position
non-elevated upper body position	Procedure or surgery	Non-elevated upper body position
Noninvasive wrist pulse oximeter (WristOx Model 3150)The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.	Device	Forty-five degrees elevated upper body position, Non-elevated upper body position
Stop-Bang questionnaireThe Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire includes snoring, tiredness, observed apneas, blood pressure, Body Mass Index, age, neck circumference and gender. The investigators will ask the patient to answer the questionnaire and measure the neck circumference.	Other	Forty-five degrees elevated upper body position, Non-elevated upper body position
Epworth Sleepiness ScaleThe Epworth Sleepiness Scale is a well-established clinical tool to quantify daytime sleepiness. It is clinically used for the diagnosis of sleep disorders. The investigators will ask the patient to complete the questionnaire and will specify that the questionnaire pertains to the patient's pre-admission condition.	Other	Forty-five degrees elevated upper body position, Non-elevated upper body position
P-SAP ScoreThe P-SAP Score is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The investigators will ask the patient to answer the questionnaire and will assess the Mallampati Score. The investigators will also measure the neck circumference and the Thyromental distance.	Other	Forty-five degrees elevated upper body position, Non-elevated upper body position
self-reported painA verbal numerical rating scale is used to asses the pain during the study-night.	Other	Forty-five degrees elevated upper body position, Non-elevated upper body position

Primary outcome

SpO2 < 90%
Time frame: 48 hours after delivery
Oxygen Saturation (SpO2) value below 90%, assessed by pulse oximetry during the first night after delivery

6 secondary outcomes

Oxygen Desaturation Index > 3
Time frame: 48 hours after delivery
Minimal & Mean SpO2
Time frame: 48 hours after delivery
P-SAP Score
Time frame: 48 hours after delivery
STOP-BANG Score
Time frame: 48 hours after delivery
Pain-score on a Verbal Numerical Rating Scale
Time frame: 48 hours after delivery
Average Pulse Rate
Time frame: 48 Hours after delivery

Results and safety

Results posted to the registry on 9 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Non-elevated Upper Body Position	50	40
Forty-five Degrees Elevated Upper Body Position	49	40

Primary outcome: SpO2 < 90%

Time frame: 48 hours after delivery. Median (Inter-Quartile Range). Unit: minutes

Measure	Non-elevated Upper Body Position n = 40	Forty-five Degrees Elevated Upper Body Position n = 40
All Types of Delivery	0.4 (0.0 to 6.4)	0.0 (0.0 to 0.5)
Vaginal Delivery	0.1 (0.0 to 0.3)	0.0 (0.0 to 0.1)
Cesarean Section	4.1 (0.9 to 19.8)	0.2 (0.0 to 1.8)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected 48 hours after delivery.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Non-elevated Upper Body Position	0 of 50 (0%)	0 of 50 (0%)	0 of 50
Forty-five Degrees Elevated Upper Body Position	0 of 49 (0%)	0 of 49 (0%)	0 of 49

Limitations and caveats (from the sponsor): The true prevalence of pregnancy-associated OSA is unknown in our cohort due to lack of diagnosis by polysomnography. We obtained questionnaires validated as OSA screening tools, but their ability to predict OSA in pregnancy remains controversial.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Matthias Eikermann, MD, PhD principal investigator

Massachusetts General Hospital

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

Questions about this trial

What is this clinical trial studying?

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 4 inclusion and 1 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 6 Jul 2018. 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. Some participants in this study may receive a placebo. 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 9 Apr 2018). 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?

SpO2 < 90% (time frame: 48 hours after delivery). 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 NCT02330055.

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 6 Jul 2018.