DOI: 10.5061/dryad.qg1b2n0
title: Data from: Modifying maternal sleep position in the third trimester of pregnancy with positional therapy: a randomized pilot trial

description: OBJECTIVE: To evaluate whether the percentage of time spent supine during
 sleep in the third trimester of pregnancy could be reduced using a
 positional therapy device (PrenaBelt) compared with a sham device. DESIGN:
 A double-blind, randomized, sham-controlled, crossover pilot trial.
 SETTING: Conducted between March 2016 and January 2017, at a single,
 tertiary-level center in Canada. PARTICIPANTS: Twenty-three participants
 entered the study. Twenty participants completed the study. Participants
 were low-risk, singleton, third-trimester pregnant women aged 18 years and
 older with BMI &lt;35 at the first antenatal appointment for the index
 pregnancy and without known fetal abnormalities, pregnancy complications,
 or medical conditions complicating sleep. INTERVENTIONS: A two-night,
 polysomnography study in a sleep laboratory. Participants were randomized
 by computer-generated, one-to-one, simple randomization to receive either
 a the PrenaBelt or a sham-PrenaBelt on the 1st night and were crossed over
 to the alternate device on the 2nd night. Allocation concealment was by
 unmarked, security-tinted, sealed envelopes. Participants, the recruiter,
 and personnel involved in setting up, conducting, scoring, and
 interpreting the polysomnogram were blinded to allocation. PRIMARY AND
 SECONDARY OUTCOME MEASURES: The primary outcome was the percentage of time
 spent supine during sleep. Secondary outcomes included maternal sleep
 architecture, respiration, self-reported sleep position, and feedback.
 RESULTS: The median percentage of sleep time supine was reduced from 16.4%
 on the sham night to 3.5% on the PrenaBelt night (pseudomedian=5.8,
 p=0.03). We were unable to demonstrate differences in sleep architecture
 or respiration. Participants underestimated the time they spent sleeping
 supine by 7.0%, and six (30%) participants indicated they would make
 changes to the PrenaBelt. There were no harms in this study. CONCLUSIONS:
 This study demonstrates that the percentage of sleep time supine during
 late pregnancy can be significantly reduced via positional therapy. TRIAL
 REGISTRATION: ClinicalTrials.gov NCT02377817
description: Supplementary File 1: R
 Code and output - Demographic AnalysisThis is a stand alone
 report containing the code and output of an R script, which was generated
 by the "Compile Report" function in RStudio (R Statistical
 Software package (version 3.2.4 (2016-03-10))). This code summarizes the
 demographic, obstetric, and sleep behaviour of the participants (collected
 via a questionnaire completed by each participant on her first sleep test)
 and compares these data between all participants whose first sleep test
 was PrenaBelt (followed by sham-PrenaBelt on the second sleep test) versus
 all participants whose first sleep test was sham-PrenaBelt (followed by
 PrenaBelt on the second sleep test).Code and output - Demographic
 Analysis.docxSupplementary File 2: R
 Code and output - PSG AnalysisThis is a stand alone
 report containing the code and output of an R script, which was generated
 by the "Compile Report" function in RStudio (R Statistical
 Software package (version 3.2.4 (2016-03-10))). This code processes the
 polysomnography (PSG) sleep reports in full, making within-participant
 (paired) comparisons and between-participant (unpaired) comparisons. The
 sleep reports were generated by Embla Sandman Elite sleep diagnostic
 software (Natus Medical Incorporated, Pleasanton, USA). The data in the
 PSG sleep reports was collected via Pro-Tech zRIP Durabelts (Philips
 Respironics, Murrysville, USA) for respiration, PT1 pressure transducers
 (BRAEBON Medical Corporation, Kanata, Canada) for airflow and snoring,
 electrodes (Natus Medical Incorporated, Pleasanton, USA) for
 ECG/EEG/EOG/EMG, and finger-tip pulse oximetry for peripheral blood oxygen
 saturation (SpO2) in accordance with the American Academy of Sleep
 Medicine 2014 guidelines. Audio and video data were also recorded and used
 in order to determine body position and snoring.Code and output - PSG
 Analysis.docxSupplementary File 3: R
 Code and output - Feedback AnalysisThis is a stand alone
 report containing the code and output of an R script, which was generated
 by the "Compile Report" function in RStudio (R Statistical
 Software package (version 3.2.4 (2016-03-10))). This code processes the
 participants' feedback on the PrenaBelt (collected via a
 questionnaire completed by each participant after each sleep test). It
 summarizes these data, completes within-participant (paired) comparison of
 these data ("before/after"), and completes between-participants
 (unpaired) comparison of these data (bulk test for differences between all
 PrenaBelt sleep test nights versus all sham-PrenaBelt
 nights).Code and output - Feedback
 Analysis.docxSupplementary File 4: R
 Code and output - Self-Report Accuracy AnalysisThis is a stand alone
 report containing the code and output of an R script, which was generated
 by the "Compile Report" function in RStudio (R Statistical
 Software package (version 3.2.4 (2016-03-10))). This code compares each
 participant's perception of her sleep behaviours (collected via a
 questionnaire completed by each participant after each sleep test) to her
 polysomnography-determined sleep behaviours (collected via audio and video
 and Embla Sandman Elite sleep diagnostic software (Natus Medical
 Incorporated, Pleasanton, USA)) in order to determine the ability of
 participants to accurately recall their sleep onset position, waking
 position, number of position changes during the night, and percentage of
 sleep time in each position.Code and output - Self-Report
 Accuracy Analysis.docx