Halifax PrenaBelt Trial

NACompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

March 15, 2016

Primary Completion Date

January 28, 2017

Study Completion Date

January 28, 2017

Conditions
SleepPregnancyStillbirthInfant, Low Birth WeightInfant, Small for Gestational AgeInfant, Very Low Birth WeightFetal Growth RetardationFetal Hypoxia
Interventions
DEVICE

PrenaBelt

"The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. PT is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition.~The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back and right side of the user when she lies on her back or right side, respectively, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back or right side."

DEVICE

Sham PrenaBelt

The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.

Trial Locations (1)

B3K 6R8

IWK Women's Health Centre, Halifax

All Listed Sponsors
collaborator

Grand Challenges Canada

OTHER

collaborator

Innovative Canadians for Change

OTHER

collaborator

Global Innovations for Reproductive Health and Life

OTHER

collaborator

Kaishin Chu Design

INDUSTRY

collaborator

Nova Scotia Health Authority

OTHER

collaborator

University of Michigan

OTHER

collaborator

Harvard University

OTHER

lead

Allan Kember

OTHER

NCT02377817 - Halifax PrenaBelt Trial | Biotech Hunter | Biotech Hunter