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Heated Humidified Continuous Positive Airway Pressure and Nasal Physiology

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ClinicalTrials.gov Identifier: NCT00850876
Recruitment Status : Completed
First Posted : February 25, 2009
Last Update Posted : April 9, 2010
Sponsor:
Information provided by:
University of Athens

Brief Summary:
Nasal continuous positive airway pressure can cause nasal side effects which can compromise compliance to therapy. Humidifiers can attenuate this effect. However, the mechanism by which humidified CPAP alleviates nasal symptoms has never been assessed objectively in OSA patients. Therefore, the purpose of this study is to examine the effect of humidified CPAP on nasal airway physiology with combined measurements of nasal resistance and level of inflammatory markers. The investigators' hypothesis is that the addition of heated humidification in CPAP decreases nasal airway resistance and nasal mucosal inflammation markers and thus, ameliorates nasal symptoms of OSAS patients.

Condition or disease
Obstructive Sleep Apnea Syndrome Nasal Obstruction

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Randomized Cross-over Trials of the Effect of Heated Humidified CPAP Versus Non-humidified CPAP on Nasal Physiology
Study Start Date : September 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine





Biospecimen Retention:   Samples Without DNA
Nasal wash will be performed using a technique adapted by Hurst et al. Briefly, a 12-French Foley catheter (Bard, Crawley, UK), modified by removal of the tip distal to the balloon, was inserted into the nostril and inflated with sufficient air to form a comfortable seal (typically 7-10ml). With the patients head flexed 45o forward, 7ml of warmed 0.9% saline will be instilled through the catheter and washed in and out of the nasal cavity three times. A portion of the pooled wash from both nostrils will be centrifuged to yield a supernatant for analysis of inflammatory cytokines (IL-6, IL-8, TNF-a, IL-10).


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects who refer to the Center of Sleep Disorders of "Evangelismos" General Hospital of Athens for suspected sleep disordered breathing.
Criteria

Inclusion Criteria:

  1. Obstructive sleep apnea syndrome defined as apnea/hypopnoea index greater than 20,
  2. Initiation of continuous positive airway pressure, and
  3. Symptomatic nasal obstruction.

Exclusion Criteria:

  1. No medication known to influence nasal resistance (antihistamines, vasoconstrictors, vasodilators, topical or systemic steroids, and recreation drugs),
  2. No smoking,
  3. No upper or lower respiratory tract disease (e.g. upper respiratory tract infection, rhinitis, sinusitis, chronic obstructive pulmonary disease), including a history of nasal allergy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850876


Locations
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Greece
Department of Critical Care and Pulmonary Services, Evangelismos Hospital
Athens, Greece, 10675
Sponsors and Collaborators
University of Athens
Investigators
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Principal Investigator: Ioannis Koutsourelakis, MD 1Center of Sleep Disorders Medical School of Athens University, Department of Critical Care and Pulmonary Services

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ioannis Koutsourelakis, 1Center of Sleep Disorders Medical School of Athens University, Department of Critical Care and Pulmonary Services
ClinicalTrials.gov Identifier: NCT00850876     History of Changes
Other Study ID Numbers: UOA-12008
First Posted: February 25, 2009    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: April 2010
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Nasal Obstruction
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases
Nose Diseases
Airway Obstruction
Respiratory Insufficiency
Otorhinolaryngologic Diseases