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Sleep-Disordered Breathing in Chronic SCI

29. oktober 2020 opdateret af: Shirin Shafazand, University of Miami

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

42

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Florida
      • Miami, Florida, Forenede Stater, 33125
        • Miami VA Hospital
      • Miami, Florida, Forenede Stater, 33136
        • Miami Project to Cure Paralysis, University of Miami Miller School of Medicine
    • Michigan
      • Detroit, Michigan, Forenede Stater, 48201
        • Wayne State University
      • Detroit, Michigan, Forenede Stater, 48201
        • John D Dingell VA Medical Center

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: AutoPAP
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.
Enhed: 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).

Andre navne:
  • CPAP
  • IntelliPAP AutoAdjust®
Sham-komparator: Sham PAP
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.
Enhed: 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)./

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cognitive Functioning as Measured by PASAT
Tidsramme: 16 weeks
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Miami

Samarbejdspartnere

Wayne State University
United States Department of Defense

Efterforskere

  • Ledende efterforsker: Shirin Shafazand, MD, MS, University of Miami Miller School of Medicine; Pulmonary and Critical Care Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. maj 2014

Primær færdiggørelse (Faktiske)

30. september 2018

Studieafslutning (Faktiske)

30. september 2018

Datoer for studieregistrering

Først indsendt

25. juni 2014

Først indsendt, der opfyldte QC-kriterier

25. juni 2014

Først opslået (Skøn)

27. juni 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

2. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. oktober 2020

Sidst verificeret

1. oktober 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20130161
  • # W81XWH-13-1-0479 (Andet bevillings-/finansieringsnummer: Department of Defense (DoD))

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ja

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