Sleep-Disordered Breathing in Chronic SCI

NACompletedINTERVENTIONAL
Enrollment

42

Participants

Timeline

Start Date

May 31, 2014

Primary Completion Date

September 30, 2018

Study Completion Date

September 30, 2018

Conditions
Spinal Cord InjurySleep Apnea, Obstructive
Interventions
DEVICE

AutoPAP

"PAP will be delivered by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.~AutoPAP treatment 7 nights a week for four months (16 weeks)."

DEVICE

Sham PAP

"Sham PAP treatment will be delivered by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events. The pressure is too low to eliminate respiratory events and serves as sham or sub-therapeutic PAP.~Sham PAP treatment 7 nights a week for four months (16 weeks)./"

Trial Locations (4)

33125

Miami VA Hospital, Miami

33136

Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami

48201

John D Dingell VA Medical Center, Detroit

Wayne State University, Detroit

All Listed Sponsors
collaborator

United States Department of Defense

FED

collaborator

Wayne State University

OTHER

lead

University of Miami

OTHER

NCT02176928 - Sleep-Disordered Breathing in Chronic SCI | Biotech Hunter | Biotech Hunter