NCT01719224

Brief Summary

The investigators hypothesized that sleeping in a 45 degrees elevated body position decreases the likelihood of upper airway vulnerability to collapse early after delivery. Furthermore, the investigators want to elucidate the anatomical and physiological risk factors that contribute in the upper airway obstruction in post-partum patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 1, 2012

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
3 years until next milestone

Results Posted

Study results publicly available

December 15, 2017

Completed
Last Updated

December 15, 2017

Status Verified

May 1, 2017

Enrollment Period

2.6 years

First QC Date

October 30, 2012

Results QC Date

March 21, 2017

Last Update Submit

May 10, 2017

Conditions

Sleep Disordered BreathingUpper Airway CollapsibilityUpper Airway Obstruction

Outcome Measures

Primary Outcomes (1)

  • Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep

    We conduct polysomnography in non-elevated and 45 degrees elevated body position, to show the effect of body position in context of sleep disordered breathing.We collect data of the apnea-hypopnea-index, central apneas, obstructive apneas and oxygen.

    48 hours after delivery

Secondary Outcomes (1)

  • Minimum Upper Airway Cross-sectional Area: to Elucidate the Anatomical and Physiological Risk Factors That Contribute to the Upper Airway Obstruction in Post-partum Patients

    48 hours after delivery

Study Arms (2)

Elevated body position

ACTIVE COMPARATOR

We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.

Procedure: elevated body position

supine body position

ACTIVE COMPARATOR

We collect data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen, by comparing supine to 45 degrees elevated body position.

Procedure: supine body position

Interventions

elevated body positionPROCEDURE

45 degrees elevated upper body position

Elevated body position
supine body positionPROCEDURE

non-elevated upper body position

supine body position

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Postpartum mothers within 48 hours of delivery in a major academic teaching hospital.
  • 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

You may not qualify if:

  • Age under 18 years.
  • History of pre-existing pulmonary and cardiac diseases, including bronchial asthma, cystic fibrosis, chronic obstructive lung disease, neck and chest tumors (thyroid, mediastinal, etc.), irradiation to the neck and/or chest, and congenital airway deformities, other critically-ill conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

  • Zaremba S, Mueller N, Heisig AM, Shin CH, Jung S, Leffert LR, Bateman BT, Pugsley LJ, Nagasaka Y, Duarte IM, Ecker JL, Eikermann M. Elevated upper body position improves pregnancy-related OSA without impairing sleep quality or sleep architecture early after delivery. Chest. 2015 Oct;148(4):936-944. doi: 10.1378/chest.14-2973.

    PMID: 25905714DERIVED

MeSH Terms

Conditions

Sleep Apnea SyndromesAirway Obstruction

Interventions

Supine Position

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesRespiratory Insufficiency

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Limitations and Caveats

Limitations include the fact that we report single-center-data and the inability draw conclusions on long-term outcome due to cross-over study-design. No direct implications on sleep-apnea during pregnancy.

Results Point of Contact

Title
Matthias Eikermann, MD, PhD
Organization
Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
meikermann@partners.org
617-643-7735

Study Officials

  • Matthias Eikermann, MD, Ph.D

    Massachusetts General Hospital Department of Anesthesia, Critical Care and Pain Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 30, 2012

First Posted

November 1, 2012

Study Start

March 1, 2012

Primary Completion

October 1, 2014

Study Completion

December 1, 2014

Last Updated

December 15, 2017

Results First Posted

December 15, 2017

Record last verified: 2017-05

Locations

US(1)