Obstructive Sleep Apnea SyndromeNCT00850876
Heated Humidified Continuous Positive Airway Pressure and Nasal Physiology
An observational study of Obstructive Sleep Apnea Syndrome and Nasal Obstruction, run by University of Athens at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome, Nasal Obstruction
- How many people
- 20 participants
- Where
- 1 siteGreece
- Study dates
- Sep 2008to Jun 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who refer to the Center of Sleep Disorders of "Evangelismos" General Hospital of Athens for suspected sleep disordered breathing.
Who may be able to join
- Obstructive sleep apnea syndrome defined as apnea/hypopnoea index greater than 20,
- Initiation of continuous positive airway pressure, and
- Symptomatic nasal obstruction.
Who cannot join
- No medication known to influence nasal resistance (antihistamines, vasoconstrictors, vasodilators, topical or systemic steroids, and recreation drugs),
- No smoking,
- 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.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Critical Care and Pulmonary Services, Evangelismos Hospital
Athens, 10675
About this study
Official title: Randomized Cross-over Trials of the Effect of Heated Humidified CPAP Versus Non-humidified CPAP on Nasal Physiology
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.
Read the detailed description
Introduction-Rationale:
Nasal continuous positive airway pressure (CPAP) is considered to be the "gold standard" of obstructive sleep apnoea (OSA) treatment [1]. The most common side effects are nasal congestion, stuffiness or dryness and rhinorrhea which have been reported in up to 68% of patients responding to a questionnaire about nasal CPAP. In many of them, CPAP compliance is accordingly compromised.
The mechanisms by which CPAP provokes nasal symptoms have been thoroughly studied only in healthy volunteers and a rodent model. Indeed, Richards et al demonstrated that mouth leaks causing high unidirectional nasal airflow increased nasal airway resistance and this response could be largely prevented by heated humidification of the inspired air. Similarly, Togias et al showed an elevated release of inflammatory mediators (histamine, prostaglandin D2, kinins) in nasal wash fluids when compressed cold and dry air was delivered through the nose. This effect was also prevented when warm and moist air was delivered. More recently, Almendros et al provided evidence that CPAP use in rats triggered early nasal inflammation.
Of the variety of methods used to treat nasal symptoms during CPAP treatment, the most common is humidification of the inspired air. However, the mechanism Oby which humidified CPAP attenuates 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. Our 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.
Study design:
BASELINE: 1. NASAL SYMPTOMS 2. NASAL RESISTANCE 3. NASAL WASH (IL-6, IL-8, TNF-a, IL-10)
3 weeks humidified CPAP --------------> 3 weeks non-humidified CPAP <--------------
AFTER TREATMENT: 1. NASAL SYMPTOMS 2. NASAL RESISTANCE 3. NASAL WASH (IL-6, IL-8, TNF-a, IL-10)
Methods:
- Nasal symptoms will be assessed using a five point Nasal Score. Each of the five principal nasal symptoms of rhinorrhoea, post-nasal drip, sneezing, impaired sense of smell and nasal blockage will be binary coded as present/increased over baseline (1) or absent/not (0) and summed to yield a total Nasal Score between zero and five.
- Nasal resistance will be assessed by active anterior and posterior rhinomanometry in both seated and supine (for 10 min) positions.
- 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.
By this protocol, the following are expected: a) the reason for potential congestion and inflammatory response is cold and dry air passing through the nostrils (mechanical irritation cannot be the reason, as the pressure is equivalent in both sessions), and b) heated and humidified CPAP prevents (and not treats) nasal congestion.
- Medical subject headings
- Sleep Apnea, Obstructive, Nasal Obstruction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Athens
- Sponsor type
- University, hospital or other
- Investigators
- Ioannis Koutsourelakis, MD, Principal investigator, 1Center of Sleep Disorders Medical School of Athens University, Department of Critical Care and Pulmonary Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00850876
- Sponsor's protocol ID
- UOA-12008
- Status last verified
- Apr 2010
- First submitted
- 24 Feb 2009
- Last updated
- 9 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Kushida CA, Chediak A, Berry RB, Brown LK, Gozal D, Iber C, Parthasarathy S, Quan SF, Rowley JA; Positive Airway Pressure Titration Task Force; American Academy of Sleep Medicine. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):157-71.
PubMed 18468315Willing S, San Pedro M, Driver HS, Munt P, Fitzpatrick MF. The acute impact of continuous positive airway pressure on nasal resistance: a randomized controlled comparison. J Appl Physiol (1985). 2007 Mar;102(3):1214-9. doi: 10.1152/japplphysiol.00639.2006. Epub 2006 Dec 7.
PubMed 17158250Randerath WJ, Meier J, Genger H, Domanski U, Ruhle KH. Efficiency of cold passover and heated humidification under continuous positive airway pressure. Eur Respir J. 2002 Jul;20(1):183-6. doi: 10.1183/09031936.02.00267902.
PubMed 12166568Mador MJ, Krauza M, Pervez A, Pierce D, Braun M. Effect of heated humidification on compliance and quality of life in patients with sleep apnea using nasal continuous positive airway pressure. Chest. 2005 Oct;128(4):2151-8. doi: 10.1378/chest.128.4.2151.
PubMed 16236868Bossi R, Piatti G, Roma E, Ambrosetti U. Effects of long-term nasal continuous positive airway pressure therapy on morphology, function, and mucociliary clearance of nasal epithelium in patients with obstructive sleep apnea syndrome. Laryngoscope. 2004 Aug;114(8):1431-4. doi: 10.1097/00005537-200408000-00022.
PubMed 15280722Hurst JR, Perera WR, Wilkinson TM, Donaldson GC, Wedzicha JA. Systemic and upper and lower airway inflammation at exacerbation of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2006 Jan 1;173(1):71-8. doi: 10.1164/rccm.200505-704OC. Epub 2005 Sep 22.
PubMed 16179639Richards GN, Cistulli PA, Ungar RG, Berthon-Jones M, Sullivan CE. Mouth leak with nasal continuous positive airway pressure increases nasal airway resistance. Am J Respir Crit Care Med. 1996 Jul;154(1):182-6. doi: 10.1164/ajrccm.154.1.8680678.
PubMed 8680678Togias AG, Naclerio RM, Proud D, Fish JE, Adkinson NF Jr, Kagey-Sobotka A, Norman PS, Lichtenstein LM. Nasal challenge with cold, dry air results in release of inflammatory mediators. Possible mast cell involvement. J Clin Invest. 1985 Oct;76(4):1375-81. doi: 10.1172/JCI112113.
PubMed 2414318Almendros I, Acerbi I, Vilaseca I, Montserrat JM, Navajas D, Farre R. Continuous positive airway pressure (CPAP) induces early nasal inflammation. Sleep. 2008 Jan;31(1):127-31. doi: 10.1093/sleep/31.1.127.
PubMed 18220086Koutsourelakis I, Vagiakis E, Perraki E, Karatza M, Magkou C, Kopaka M, Roussos C, Zakynthinos S. Nasal inflammation in sleep apnoea patients using CPAP and effect of heated humidification. Eur Respir J. 2011 Mar;37(3):587-94. doi: 10.1183/09031936.00036910. Epub 2010 Jul 1.
PubMed 20595158
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Cross-over Trials of the Effect of Heated Humidified CPAP Versus Non-humidified CPAP on Nasal Physiology
- ClinicalTrials.gov ID
- NCT00850876
- Acronym / sponsor ID
- UOA-12008
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of AthensUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction-Rationale:
Nasal continuous positive airway pressure (CPAP) is considered to be the "gold standard" of obstructive sleep apnoea (OSA) treatment [1]. The most common side effects are nasal congestion, stuffiness or dryness and rhinorrhea which have been reported in up to 68% of patients responding to a questionnaire about nasal CPAP. In many of them, CPAP compliance is accordingly compromised.
The mechanisms by which CPAP provokes nasal symptoms have been thoroughly studied only in healthy volunteers and a rodent model. Indeed, Richards et al demonstrated that mouth leaks causing high unidirectional nasal airflow increased nasal airway resistance and this response could be largely prevented by heated humidification of the inspired air. Similarly, Togias et al showed an elevated release of inflammatory mediators (histamine, prostaglandin D2, kinins) in nasal wash fluids when compressed cold and dry air was delivered through the nose. This effect was also prevented when warm and moist air was delivered. More recently, Almendros et al provided evidence that CPAP use in rats triggered early nasal inflammation.
Of the variety of methods used to treat nasal symptoms during CPAP treatment, the most common is humidification of the inspired air. However, the mechanism Oby which humidified CPAP attenuates 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. Our 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.
Study design:
BASELINE: 1. NASAL SYMPTOMS 2. NASAL RESISTANCE 3. NASAL WASH (IL-6, IL-8, TNF-a, IL-10)
3 weeks humidified CPAP --------------> 3 weeks non-humidified CPAP <--------------
AFTER TREATMENT: 1. NASAL SYMPTOMS 2. NASAL RESISTANCE 3. NASAL WASH (IL-6, IL-8, TNF-a, IL-10)
Methods:
- Nasal symptoms will be assessed using a five point Nasal Score. Each of the five principal nasal symptoms of rhinorrhoea, post-nasal drip, sneezing, impaired sense of smell and nasal blockage will be binary coded as present/increased over baseline (1) or absent/not (0) and summed to yield a total Nasal Score between zero and five.
- Nasal resistance will be assessed by active anterior and posterior rhinomanometry in both seated and supine (for 10 min) positions.
- 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.
By this protocol, the following are expected: a) the reason for potential congestion and inflammatory response is cold and dry air passing through the nostrils (mechanical irritation cannot be the reason, as the pressure is equivalent in both sessions), and b) heated and humidified CPAP prevents (and not treats) nasal congestion.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who refer to the Center of Sleep Disorders of "Evangelismos" General Hospital of Athens for suspected sleep disordered breathing.
Key inclusion criteria (3 listed)
- Obstructive sleep apnea syndrome defined as apnea/hypopnoea index greater than 20,
- Initiation of continuous positive airway pressure, and
- Symptomatic nasal obstruction.
Key exclusion criteria (3 listed)
- No medication known to influence nasal resistance (antihistamines, vasoconstrictors, vasodilators, topical or systemic steroids, and recreation drugs),
- No smoking,
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2010.
- Background: PubMed 18468315Kushida CA, Chediak A, Berry RB, Brown LK, Gozal D, Iber C, Parthasarathy S, Quan SF, Rowley JA; Positive Airway Pressure Titration Task Force; American Academy of Sleep Medicine. Clinical guidelines for the manual titration of positive airway pressure in patients with obstructive sleep apnea. J Clin Sleep Med. 2008 Apr 15;4(2):157-71.
- Background: PubMed 17158250Willing S, San Pedro M, Driver HS, Munt P, Fitzpatrick MF. The acute impact of continuous positive airway pressure on nasal resistance: a randomized controlled comparison. J Appl Physiol (1985). 2007 Mar;102(3):1214-9. doi: 10.1152/japplphysiol.00639.2006. Epub 2006 Dec 7.
- Background: PubMed 12166568Randerath WJ, Meier J, Genger H, Domanski U, Ruhle KH. Efficiency of cold passover and heated humidification under continuous positive airway pressure. Eur Respir J. 2002 Jul;20(1):183-6. doi: 10.1183/09031936.02.00267902.
- Background: PubMed 16236868Mador MJ, Krauza M, Pervez A, Pierce D, Braun M. Effect of heated humidification on compliance and quality of life in patients with sleep apnea using nasal continuous positive airway pressure. Chest. 2005 Oct;128(4):2151-8. doi: 10.1378/chest.128.4.2151.
- Background: PubMed 15280722Bossi R, Piatti G, Roma E, Ambrosetti U. Effects of long-term nasal continuous positive airway pressure therapy on morphology, function, and mucociliary clearance of nasal epithelium in patients with obstructive sleep apnea syndrome. Laryngoscope. 2004 Aug;114(8):1431-4. doi: 10.1097/00005537-200408000-00022.
- Background: PubMed 16179639Hurst JR, Perera WR, Wilkinson TM, Donaldson GC, Wedzicha JA. Systemic and upper and lower airway inflammation at exacerbation of chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2006 Jan 1;173(1):71-8. doi: 10.1164/rccm.200505-704OC. Epub 2005 Sep 22.
- Background: PubMed 8680678Richards GN, Cistulli PA, Ungar RG, Berthon-Jones M, Sullivan CE. Mouth leak with nasal continuous positive airway pressure increases nasal airway resistance. Am J Respir Crit Care Med. 1996 Jul;154(1):182-6. doi: 10.1164/ajrccm.154.1.8680678.
- Background: PubMed 2414318Togias AG, Naclerio RM, Proud D, Fish JE, Adkinson NF Jr, Kagey-Sobotka A, Norman PS, Lichtenstein LM. Nasal challenge with cold, dry air results in release of inflammatory mediators. Possible mast cell involvement. J Clin Invest. 1985 Oct;76(4):1375-81. doi: 10.1172/JCI112113.
- Background: PubMed 18220086Almendros I, Acerbi I, Vilaseca I, Montserrat JM, Navajas D, Farre R. Continuous positive airway pressure (CPAP) induces early nasal inflammation. Sleep. 2008 Jan;31(1):127-31. doi: 10.1093/sleep/31.1.127.
- Derived from this study: PubMed 20595158Koutsourelakis I, Vagiakis E, Perraki E, Karatza M, Magkou C, Kopaka M, Roussos C, Zakynthinos S. Nasal inflammation in sleep apnoea patients using CPAP and effect of heated humidification. Eur Respir J. 2011 Mar;37(3):587-94. doi: 10.1183/09031936.00036910. Epub 2010 Jul 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ioannis Koutsourelakis, MD principal investigator
1Center of Sleep Disorders Medical School of Athens University, Department of Critical Care and Pulmonary Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Sleep Apnea Syndrome and Nasal Obstruction, run by University of Athens at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00850876, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2010.