A comparison of CPAP and CPAPFLEX in the treatment of obstructive sleep apnea in World Trade Center responders: study protocol for a randomized controlled trial.
Trials
; 16: 403, 2015 Sep 10.
Article
en En
| MEDLINE
| ID: mdl-26357928
ABSTRACT
BACKGROUND:
Following the World Trade Center disaster, a large number of individuals involved in rescue and recovery activity were exposed to significant amounts of dust, and reported symptoms of chronic nasal and sinus inflammation. An unusually high prevalence of obstructive sleep apnea (OSA) has also been observed in this World Trade Center Responder population. This project aims to examine the relationship between nasal pathology and OSA. Our hypothesis is that increased nasal resistance due to nasal inflammation predisposes to OSA in this population. Continuous Positive Airway Pressure (CPAP) is the standard therapy for OSA but despite its efficacy has poor adherence. Subjects with high nasal resistance may have greater difficulty in tolerating this therapy than those who do not have high nasal resistance. Reduction of excess expiratory positive pressure by the modality known as Cflex(™) during Continuous Positive Airway Pressure therapy (CPAP(Flex)) has been suggested to improve comfort without compromising efficacy. We will compare CPAP to CPAP(Flex) in subjects with OSA. STUDYDESIGN:
Subjects with new onset habitual snoring will be screened for OSA using home sleep studies and rhinomanometry will be used to determine nasal resistance. In 400 subjects with OSA we will perform a randomized double blind cross-over study comparing CPAP to CPAP(flex), and relate nasal resistance to adherence to CPAP therapy.DISCUSSION:
This is the first multicenter trial designed to test the hypothesis that adherence to CPAP therapy relates to nasal resistance and CPAP(Flex) will improve adherence to CPAP in those subjects with high nasal resistance. We anticipate the following results from this trial 1. Increased nasal resistance is associated with decreased adherence to CPAP therapy. 2. Use of CPAP(Flex) improves adherence with CPAP therapy in subjects with high nasal resistance, but not in those with low nasal resistance. 3. The benefit of CPAP(Flex) on adherence is greatest when offered at CPAP therapy initiation rather than as a "rescue" therapy in subjects with high nasal resistance. TRIAL REGISTRATION ClinicalTrials.gov Identifier NCT01753999, Date 12 December 2012.
Texto completo:
1
Banco de datos:
MEDLINE
Asunto principal:
Obstrucción Nasal
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Salud Laboral
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Apnea Obstructiva del Sueño
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Presión de las Vías Aéreas Positiva Contínua
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Ataques Terroristas del 11 de Septiembre
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Socorristas
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Cavidad Nasal
Tipo de estudio:
Clinical_trials
/
Diagnostic_studies
/
Etiology_studies
/
Guideline
/
Prognostic_studies
/
Risk_factors_studies
Límite:
Humans
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Trials
Asunto de la revista:
MEDICINA
/
TERAPEUTICA
Año:
2015
Tipo del documento:
Article
País de afiliación:
Estados Unidos