Trial Outcomes & Findings for Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention (NCT NCT01719224)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

55 participants

Primary outcome timeframe

48 hours after delivery

Results posted on

2017-12-15

Participant Flow

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

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.

Participant milestones

Participant milestones
Measure	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.	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.
Intervention 1: Sleeping Position 1 STARTED	18	18
Intervention 1: Sleeping Position 1 COMPLETED	14	16
Intervention 1: Sleeping Position 1 NOT COMPLETED	4	2
Intervention 2: Position Change(At 3.5h) STARTED	14	16
Intervention 2: Position Change(At 3.5h) COMPLETED	14	16
Intervention 2: Position Change(At 3.5h) NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	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.
Intervention 1: Sleeping Position 1 Withdrawal by Subject	4	2

Baseline Characteristics

Incidence of Sleep-disordered Breathing and Upper Airway Collapsibility in Postpartum Patients and Its Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Study Population (N=55) n=55 Participants Fifty-five patients were enrolled within 48 hours after delivery from two newborn family units at MGH hospital.
Age, Continuous	33.13 years STANDARD_DEVIATION 5.1 • n=5 Participants
Sex: Female, Male Female	55 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
BMI prior to pregnancy	25.82 kg/m^2 STANDARD_DEVIATION 6.8 • n=5 Participants
BMI end of pregnancy	30.84 kg/m² STANDARD_DEVIATION 7 • n=5 Participants
Delivery method: C-Section	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Elevated Upper Body Position n=34 Participants 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	Non-elevated Upper Body Position n=32 Participants We collected 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	45 Degree Elevation Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a non-elevated (supine) 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	7.7 Apneas and hypopneas per hour of sleep Standard Error 2.2	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Elevated Upper Body Position n=55 Participants 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	Non-elevated Upper Body Position n=55 Participants We collected 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	45 Degree Elevation n=55 Participants Fifty-five patients were enrolled within 48 hours after delivery, and all of them successfully completed acoustic pharyngometry during wakefulness. Each patient had the pharyngemtry measurements in a non-elevated (supine) 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	1.35 cm^2 Standard Deviation 0.1	1.46 cm^2 Standard Deviation 0.1

Adverse Events

Elevated Body Position

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Supine Body Position

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Matthias Eikermann, MD, PhD

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

Phone: 617-643-7735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place