Sleep-Disordered Breathing in Chronic SCI



Status:Completed
Conditions:Insomnia Sleep Studies, Peripheral Vascular Disease, Hospital, Hospital, Orthopedic, Pulmonary
Therapuetic Areas:Cardiology / Vascular Diseases, Psychiatry / Psychology, Pulmonary / Respiratory Diseases, Orthopedics / Podiatry, Other
Healthy:No
Age Range:18 - Any
Updated:1/5/2019
Start Date:May 2014
End Date:September 30, 2018

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Sleep-Disordered Breathing in Chronic SCI: A Randomized Controlled Trial of Treatment Impact on Cognition, Quality of Life, and Cardiovascular Disease

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.

Investigators will examine the effect of PAP therapy and sleep apnea on thinking (especially
memory, learning and concentration), quality of life, 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, pain severity, mood, and
HRQOL 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.

Inclusion Criteria:

- Chronic tetraplegia or paraplegia (C4-L1)

- American Spinal Injury Association (ASIA) Impairment Scale A, B, C or D

- 18 years and older

- At least one year post injury

- Hearing and vision suitable for comprehension of instructions, and perception of
cognitive test stimuli

- No color blindness as measured by a brief screen with color perception Ishihara cards

- Stable medical condition for 2 weeks prior to enrollment. Patients admitted to
hospital will be eligible for enrolment if the acute illness precipitating admission
is in recovery phase for 2 weeks or longer

Exclusion Criteria:

- Diagnosis of SDB and successful positive airway pressure (PAP) therapy prior to
injury. Those with a diagnosis of SDB post injury who are not receiving therapy for
SDB (PAP, surgical, and/or oral appliance) are eligible for study enrollment

- Patients who are intubated, have a tracheostomy, and/or are using long term
invasive/non-invasive positive pressure ventilation

- Participants with predominant central sleep apnea on PSG requiring bi-level PAP
therapy

- Severe traumatic brain injury (GCS < 8 at first assessment)

- Unable to understand or read English at a grade 5 level

- Inability to provide informed consent

- Evidence of advanced neurological or systemic disease that may affect cognitive
functioning (e.g., Alzheimer's disease, Dementia, Parkinson's disease)

- Significant aphasia or language impairments

- Positive airway pressure therapy may be contraindicated in some patients with the
following preexisting conditions:

- severe bullous lung disease

- pneumothorax

- pathologically low blood pressure

- dehydration

- cerebrospinal fluid leak, recent cranial surgery, or trauma.
We found this trial at
4
sites
Miami, Florida 33125
Phone: 305-243-7122
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5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: M. S Badr, MD, MBA
Phone: 313-576-3548
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, Michigan 48201
Principal Investigator: M. S Badr, MD, MBA
Phone: 313-576-3548
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Miami, Florida 33136
Principal Investigator: Shirin Shafazand, MD
Phone: 305-243-7122
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