NCT02176928

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 27, 2014

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2018

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

November 2, 2020

Completed
Last Updated

November 2, 2020

Status Verified

October 1, 2020

Enrollment Period

4.4 years

First QC Date

June 25, 2014

Results QC Date

November 25, 2019

Last Update Submit

October 29, 2020

Conditions

Spinal Cord InjurySleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

  • Cognitive Functioning as Measured by PASAT

    Paced Serial Addition Test (PASAT) measures divided attention and memory. PASAT has a total score ranging from 0 to 60 with the lower scores indicate greater impairment of attention.

    16 weeks

Study Arms (2)

AutoPAP

ACTIVE COMPARATOR

PAP treatment will be delivered for four months 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.

Device: AutoPAP

Sham PAP

SHAM COMPARATOR

Sham PAP treatment will be delivered for four months 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.

Device: Sham PAP

Interventions

AutoPAPDEVICE

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).

Also known as: IntelliPAP AutoAdjust®, CPAP
AutoPAP
Sham PAPDEVICE

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)./

Sham PAP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic tetraplegia or paraplegia (C4-L1)
  • American Spinal Injury Association (ASIA) Impairment Scale A, B, C or D
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Miami VA Hospital

Miami, Florida, 33125, United States

Location

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

Miami, Florida, 33136, United States

Location

John D Dingell VA Medical Center

Detroit, Michigan, 48201, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

  • Graco M, Schembri R, Cross S, Thiyagarajan C, Shafazand S, Ayas NT, Nash MS, Vu VH, Ruehland WR, Chai-Coetzer CL, Rochford P, Churchward T, Green SE, Berlowitz DJ. Diagnostic accuracy of a two-stage model for detecting obstructive sleep apnoea in chronic tetraplegia. Thorax. 2018 Sep;73(9):864-871. doi: 10.1136/thoraxjnl-2017-211131. Epub 2018 May 7.

    PMID: 29735608DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesSleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake Disorders

Limitations and Caveats

only 39% of subjects were using PAP more than 4 hours a night by end of week 1 and this number dropped to less than 30% by end of month 4, this may impact final conclusions. Small sample size.

Results Point of Contact

Title
Shirin Shafazand, MD, MS
Organization
University of Miami
sshafazand@med.miami.edu
305-243-7888

Study Officials

  • Shirin Shafazand, MD, MS

    University of Miami Miller School of Medicine; Pulmonary and Critical Care Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

June 25, 2014

First Posted

June 27, 2014

Study Start

May 1, 2014

Primary Completion

September 30, 2018

Study Completion

September 30, 2018

Last Updated

November 2, 2020

Results First Posted

November 2, 2020

Record last verified: 2020-10

Locations

US(4)