Sleep Disordered Breathing, Upper Airway Collapsibility, Upper Airway Obstruction
Conditions
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.
Detailed description
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.
Interventions
PROCEDUREelevated body position
45 degrees elevated upper body position
PROCEDUREsupine body position
non-elevated upper body position
Sponsors
Massachusetts General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Postpartum mothers within 48 hours of delivery in a major academic teaching hospital. 2. Age over 18 years. 3. Admitted to the Massachusetts General Hospital OB service for the delivery. 4. Interventions will be randomly assigned to the patients enrolled in this study
Exclusion criteria
1. Age under 18 years. 2. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep | 48 hours after delivery | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
Countries
United States
Participant flow
Recruitment details
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
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Total Study Population (N=55) Fifty-five patients were enrolled within 48 hours after delivery from two newborn family units at MGH hospital. | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Intervention 1: Sleeping Position 1 | Withdrawal by Subject | 4 | 2 |
Baseline characteristics
| Characteristic | Total Study Population (N=55) |
|---|---|
| Age, Continuous | 33.13 years STANDARD_DEVIATION 5.1 |
| BMI end of pregnancy | 30.84 kg/m² STANDARD_DEVIATION 7 |
| BMI prior to pregnancy | 25.82 kg/m^2 STANDARD_DEVIATION 6.8 |
| Delivery method: C-Section | 11 participants |
| Sex: Female, Male Female | 55 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 48 hours after delivery
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elevated Upper Body Position | Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep | 4.5 Apneas and hypopneas per hour of sleep | Standard Error 1.4 |
| Non-elevated Upper Body Position | Apnea-hypopnea Index (AHI), Defined as the Number of Apneas and Hypopneas Per Hour of Sleep | 7.7 Apneas and hypopneas per hour of sleep | Standard Error 2.2 |
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.
Time frame: 48 hours after delivery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elevated Upper Body Position | 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 | 1.54 cm^2 | Standard Deviation 0.1 |
| Non-elevated Upper Body Position | 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 | 1.35 cm^2 | Standard Deviation 0.1 |
| 45 Degree Elevation | 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 | 1.46 cm^2 | Standard Deviation 0.1 |