Sleep-Disordered Breathing in Chronic SCI

Status Completed

Clinical Trial Summary

The purpose of this study is to examine impact of Sleep Disordered Breathing (SDB) treatment in persons with chronic Spinal Cord Injury (SCI). The central hypothesis is that the treatment of SDB with Positive Airway Pressure (PAP) will improve cognition, sleep quality, health related quality of life (HRQOL), pain and Cardiovascular Disease (CVD) surrogate measures in persons with chronic SCI.

Clinical Trial Description

Investigators will examine the effect of PAP therapy and sleep apnea on thinking (especially memory, learning and concentration), sleep quality, and risks for future heart (cardiovascular) problems in persons with chronic spinal cord injury (SCI). SDB is a condition where there are pauses in breathing or shallow breathing during sleep due to airway narrowing. This leads to low oxygen levels during sleep and sleep disruption. The usual treatment for sleep apnea is PAP (Positive Airway Pressure) worn while sleeping. This involves the use of usually a mask connected to a machine that supplies enough pressure to keep the airway open during sleep. SDB will be diagnosed in SCI participants using unattended portable level II polysomnography (PSG) (a portable at home sleep study for one night). Sleep quality (SQ), SDB risk, insomnia severity, daytime sleepiness,and mood will be measured using questionnaires. Cognitive evaluations will be completed prior to randomization on all participants who also complete a portable PSG to evaluate general and pre-morbid function, immediate verbal memory, simple and sustained attention, processing speed, and executive function. Blood and urine samples will be taken for participants with SDB diagnosis after randomization. All randomized subjects will be fitted with a nasal or full-face mask and head gear. PAP will be delivered by an auto-titrating device. These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas, and hypopneas. All subjects will be instructed to use the device nightly during sleep, for the ensuing four months. All outcome measurements will be reassessed after four months of PAP. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02176928
Study type	Interventional
Source	University of Miami
Contact
Status	Completed
Phase	N/A
Start date	May 2014
Completion date	September 30, 2018

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT02574572` - Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury	Phase 1
Recruiting	`NCT05941819` - ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury	N/A
Completed	`NCT05265377` - Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury	N/A
Recruiting	`NCT02331979` - Improving Bladder Function in SCI by Neuromodulation	N/A
Completed	`NCT02777281` - Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI	N/A
Recruiting	`NCT02978638` - Electrical Stimulation for Continence After Spinal Cord Injury	N/A
Completed	`NCT02262234` - Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study	Phase 1/Phase 2
Withdrawn	`NCT02237547` - Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT02161913` - Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers	N/A
Terminated	`NCT02080039` - Electrical Stimulation of Denervated Muscles After Spinal Cord Injury	N/A
Completed	`NCT01642901` - Zoledronic Acid in Acute Spinal Cord Injury	Phase 3
Completed	`NCT01884662` - Virtual Walking for Neuropathic Pain in Spinal Cord Injury	N/A
Terminated	`NCT01433159` - Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury	Phase 2
Completed	`NCT01471613` - Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT02149511` - Longitudinal Morphometric Changes Following SCI
Completed	`NCT01467817` - Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)	N/A
Completed	`NCT01086930` - Early Intensive Hand Rehabilitation After Spinal Cord Injury	Phase 3
Terminated	`NCT01005615` - Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury	Phase 1/Phase 2
Completed	`NCT00663663` - Telephone Intervention for Pain Study (TIPS)	N/A
Completed	`NCT01025609` - Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.