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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.
After obtaining study consent, each patient underwent measurements of upper airway cross-sectional area (CSA) during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position. This method has been previously used and validated in pregnant women.
In the patients who further gave consent for the sleep study, polysomnography (PSG) was performed throughout the entire study night. Within a crossover design, patients were randomly assigned to receive first either nonelevated or 45° elevated upper body position. Position was changed after 3.5 h by a member of the team.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| elevated body position | Procedure | 45 degrees elevated upper body position |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Each patient underwent measurements of upper airway CSA during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Eikermann, MD, Ph.D | Massachusetts General Hospital Department of Anesthesia, Critical Care and Pain Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25905714 | Derived | 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. |
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55 patients enrolled in the study and all of them successfully completed acoustic pharyngometry during wakefulness. 36 of 55 participants were randomized to receive one of the two sleeping positions first. Of those not randomized, 19 declined to participate in the overnight PSG recording.
Women during the first 48 h after delivery were included. Patients with a history of preexisting pulmonary and cardiac diseases or neck and chest tumors, as well as patients with a history of irradiation to the neck and/or chest or congenital airway deformities were not included in the study
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental: Elevated Position, Then Non-Elevated Position | In the beginning of the study night, participants were placed in a sleeping position at 45 degrees upper body elevation. After 3.5h, a study member changed the patients bed to a non-elevated position. We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen during the study night. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Intervention 1: Sleeping Position 1 |
|
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| supine body position |
| Procedure |
non-elevated upper body position |
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| 48 hours after delivery |
| FG001 | Experimental: Non-Elevated Position, Then Elevated Position | In the beginning of the study night, participants were placed in a non-elevated sleeping position. After 3.5h, a study member changed the patients bed to a 45 degrees upper body position. We collected data about the apnea- hypopnea index, obstructive and central apneas, as well as oxygen during the study night. |
| COMPLETED |
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| NOT COMPLETED |
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| Intervention 2: Position Change(At 3.5h) |
|
55 patients enrolled in the study and all of them successfully completed acoustic pharyngometry during wakefulness. 36 of 55 participants were randomized to receive one of the two sleeping positions first. Of those not randomized, 19 declined to participate in the overnight PSG recording.
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Study Population (N=55) | Fifty-five patients were enrolled within 48 hours after delivery from two newborn family units at MGH hospital. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| BMI prior to pregnancy | Mean | Standard Deviation | kg/m^2 |
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| BMI end of pregnancy | Mean | Standard Deviation | kg/m² |
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| Delivery method: C-Section | Number | participants |
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| 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 | 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. | 55 women (older than 18 years) were recruited within 48 h after delivery. Polysomnography (PSG) was performed throughout the entire study night. Within a crossover design, patients were randomly assigned to receive first either nonelevated or 45° elevated upper body position. Position was changed after 3.5 h by a member of the team. | Posted | Mean | Standard Error | Apneas and hypopneas per hour of sleep | 48 hours after delivery |
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| Secondary | 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 | Each patient underwent measurements of upper airway CSA during daytime within 48 h after delivery. The minimum upper airway CSA was measured using acoustic pharyngometry (Eccovision Acoustic Pharyngometry; Sleep Group Solutions, Inc) in sitting, 45° elevated, and nonelevated upper body position. | Posted | Mean | Standard Deviation | cm^2 | 48 hours after delivery |
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All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not monitored/assessed
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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 | Elevated Body Position | 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. elevated body position: 45 degrees elevated upper body position | 0 | 0 | 0 | 0 | ||
| EG001 | Supine Body Position | 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. supine body position: non-elevated upper body position | 0 | 0 | 0 | 0 |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matthias Eikermann, MD, PhD | Department of Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital | 617-643-7735 | meikermann@partners.org |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D000402 | Airway Obstruction |
| ID | Term |
|---|---|
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| D012131 | Respiratory Insufficiency |
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| ID | Term |
|---|---|
| D016683 | Supine Position |
| ID | Term |
|---|---|
| D011187 | Posture |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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