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De klinische studie NCT06818604 voor Spinal Cord Injuries (SCI), Sleep Disordered Breathing (SDB), Slaapapneu, Cervical Spinal Cord Injruy is nog niet rekruterend. Bekijk de kaartweergave van de Klinische Studies Radar en de AI-ontdekkingstools voor alle details. Of stel hier een vraag. | ||
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University of British ColumbiaComparing CPAP and BiPAP for Sleep-Disordered Breathing in People with Cervical Spinal Cord Injuries
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De klinische studie NCT06818604 is een interventioneel studie bij Spinal Cord Injuries (SCI), Sleep Disordered Breathing (SDB), Slaapapneu, Cervical Spinal Cord Injruy met de status nog niet rekruterend. De inclusie van 32 deelnemers start op 1 augustus 2025. De studie wordt geleid door University of British Columbia en de voltooiing is gepland op 1 september 2027. Laatste update op ClinicalTrials.gov: 10 februari 2025.
Beknopte samenvatting
Sleep-disordered breathing (SDB) is common in individuals with cervical spinal cord injuries, with studies suggesting prevalence rates ranging from 27% to 62%. The condition often leads to daytime sleepiness, fatigue, and poor participation in rehabilitation. Positive airway pressure therapy can be used to treat the condition; however, some individuals find continuous positive airway pressure (CPAP), which applies the same pressure during inhalation and exhalation, difficult to use. Bilevel positive airway pressure (BiPAP) offers different pressures for inhalation and exhalation, which may be more comfortable and potentially improve adherence in this patient population. However, limited evidence compares CPAP and BiPAP in individuals with cervical spinal cord injuries.
This pilot study will enroll 32 adult participants with cervical spinal cord injuries who have moderate to severe SDB (defined as an AHI of 15 events/hour or greater). Participants will be randomly assigned to either CPAP or BiPAP therapy for 4 weeks. Device usage per night will be measured, and data on daytime sleepiness, fatigue, and sleep quality will be collected at baseline, 2 weeks, and 4 weeks. The investigators aim to determine whether BiPAP improves adherence and symptoms compared to CPAP in this patient population.
Officiële titel
Comparison Between CPAP and BiPAP for Management of Sleep Disordered Breathing in Cervical Spinal Cord Injury Patients: a Pilot Randomized Controlled Study
Aandoeningen
Spinal Cord Injuries (SCI)Sleep Disordered Breathing (SDB)SlaapapneuCervical Spinal Cord InjruyAndere studie-ID's
- H24-01212
NCT-ID
Startdatum (Werkelijk)
2025-08-01
Laatste update geplaatst
2025-02-10
Verwachte einddatum
2027-09-01
Inschrijving (Geschat)
32
Studietype
Interventioneel
FASE
N.v.t.
Status
Nog niet rekruterend
Trefwoorden
sleep disordered breathing
Cervical Vertebrae
Obstructive Sleep Apnea
Spinal Cord Injuries
Positive Pressure Respiration
Continuous Positive Airway Pressure
Sleep Quality
Quadriplegia
Polysomnography
Tetraplegia
Sleep Wake Disorders
Diaphragmatic Paralysis
Autonomic Dysreflexia
Muscle Weakness
Nocturnal Hypoventilation
Phrenic Nerve
Pulmonary Atelectasis
Spinal Cord Compression
Ventilator Weaning
Neurological Rehabilitation
Sleep Disorders
Activities of Daily Living
Cervical Vertebrae
Obstructive Sleep Apnea
Spinal Cord Injuries
Positive Pressure Respiration
Continuous Positive Airway Pressure
Sleep Quality
Quadriplegia
Polysomnography
Tetraplegia
Sleep Wake Disorders
Diaphragmatic Paralysis
Autonomic Dysreflexia
Muscle Weakness
Nocturnal Hypoventilation
Phrenic Nerve
Pulmonary Atelectasis
Spinal Cord Compression
Ventilator Weaning
Neurological Rehabilitation
Sleep Disorders
Activities of Daily Living
Primaire doel
Behandeling
Toewijzing
Gerandomiseerd
Interventiemodel
Parallel
Blindering
Geen (Open-label)
Armen / Interventies
| Deelnemersgroep/Studiearm | Interventie/Behandeling |
|---|---|
ExperimenteelCPAP Therapy | CPAP Participants randomized to this group will receive auto-CPAP therapy. The device will be initiated by a respiratory therapist at GF Strong Rehabilitation Centre. Settings will be adjusted to achieve a device efficacy index \< 5 events per hour. |
ExperimenteelBiPAP Therapy | Bipap Participants will receive BiPAP S mode therapy for 4 weeks. The device will be initiated by a respiratory therapist at GF Strong Rehabilitation Centre with initial settings of IPAP 8 cmH2O and EPAP 3 cmH2O. Settings will be modified to a maximum tolerated level to achieve a tidal volume of 8 mL/kg ideal body weight and SpO2 \> 95%. Overnight oximetry will be performed to ensure at least 4 hours of device use, and settings will be adjusted to achieve a DEI \< 5 events per hour. |
Primaire uitkomst
Secundaire uitkomst
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Adherence to PAP Therapy | Median hours of PAP device use per night, objectively measured via device download. Additional metrics include: % days used \>4 hrs/night, total # of days used, total # of hours used. | 4 weeks |
| Uitkomstmaat | Beschrijving van de uitkomstmaat | Tijdsbestek |
|---|---|---|
Daytime Sleepiness | Measured using the Epworth Sleepiness Scale (ESS). ESS is a self-administered questionnaire that asks participants to rate their likelihood of dozing off or falling asleep in eight different situations that are common in daily life. Scores range from 0 to 24, with higher scores indicating greater daytime sleepiness. | 4 weeks |
Sleep Quality | Measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated questionnaire that assesses sleep quality over the past month. The PSQI yields seven component scores, each ranging from 0 to 3, which are summed to produce a global PSQI score ranging from 0 to 21. Higher global PSQI scores indicate poorer sleep quality. | 4 weeks |
Fatigue | Measured using the PROMIS-Fatigue (PROMIS-F) scale. The PROMIS-F is a standardized, self-reported measure of fatigue. PROMIS-F T-scores are standardized to a mean of 50 and a standard deviation of 10. Higher T-scores indicate greater fatigue. | 4 weeks |
PAP side effects | Assessed using a PAP therapy side effect survey. This survey will collect information about any side effects experienced by participants as a result of using the PAP devices. | 4 weeks |
Recruitment Rate | Helps assess the feasibility of recruiting this specific patient population for future, larger studies. Also helps us understand if there are any barriers to participation that need to be addressed in future research. Recruitment rate will be assessed as the average number of participants enrolled per month during the recruitment period. | 4 weeks |
Geschiktheidscriteria
Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
19 Years
Geslachten die in aanmerking komen voor de studie
Allen
- Age >= 19 years
- Cervical spinal cord injury (ASIA A, B, or C). This will include patients with upper (C1-C4) and lower (C5-C7) spinal cord injuries
- Presence of sleep disordered breathing, defined as AHI > =15 events/hour by home sleep apnea test (HSAT)
- On CPAP or BiPAP prior to spinal cord injury
- Hypoventilation syndrome (elevated venous carbon dioxide, PvCO2>50 mm Hg)
University of British Columbia319 actieve klinische studies om te verkennenVerantwoordelijke instantie
Najib Ayas, Hoofdonderzoeker, Principal Investigator, University of British Columbia
Centraal Contactpersoon
Contact: Najib Ayas, 604-875-4122, [email protected]
Contact: Viet Vu, 604-734-1313, [email protected]
1 Studielocaties in 1 landen
British Columbia
GF Strong Rehabilitation Centre, Vancouver, British Columbia, V5Z 2G9, Canada
Viet Vu, Contact, 604-734-1313, [email protected]