Halifax PrenaBelt Trial

The utility of the PrenaBelt in modifying maternal sleeping position and the effect of the PrenaBelt on maternal respiratory and cardiovascular parameters during sleep and sleep staging in the third trimester of pregnancy will be evaluated via a two-night, randomized, cross-over, sham-controlled, triple-blind, sleep study in third trimester pregnant women. Two nights: one night with a positional therapy (PT) device and one night with sham-PT device to determine treatment effect on outcomes. Randomized: participants will be randomized to treatment order: sham-PT on first night, then PT on second night, or vice versa. This will avoid the potential impact of changes to sleep across the two nights resulting from familiarization with the equipment, which could bias the results. Cross-over: on the second night, each participant will be crossed over from PT to sham-PT (or vice versa, depending on randomization order) to allow each participant to act as her own control for comparison of treatment effect on outcomes. Sham-controlled: a sham-PT device that has the same fit and form of the PT device but without the ability of function (pressure points) will be used as a control. The purpose of a sham-PT device is to identify any specific benefit of one element of a PT device (e.g., fit or form) above and beyond all benefits that might be attributed to everything else about that device (e.g., function). Note that there is no established effective therapy for the population for the indication under study. Triple blind: participants, sleep technologists monitoring and scoring the sleep tests, and the specialized sleep physician reviewing and reporting the sleep test results will be blinded to the intervention received each night. Laboratory: conducting this study in a controlled lab setting will allow for continual, real time monitoring of various cardiovascular, respiratory, and sleep parameters of each participant by the sleep technologist. This contributes to a more controlled and safer study overall. Sleep test: body position, various cardiovascular and respiratory parameters, and sleep parameters will be continuously recorded while the participants are sleeping. Sleep lab procedures will be followed by the personnel conducting, scoring, reviewing, and reporting the sleep tests from participant preparation through discharge