Nasal Tramazoline and Dexamethazone in Obstructive Sleep Apnea (OSA) Patients Tramazoline and (NTD)
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Nasal tramazoline with dexamethazone
Nasal placebo
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome
Eligibility Criteria
Inclusion Criteria:
- OSA patients (AHI > 10 events/h), and
- normal nasal resistance measured in seated and supine position with active anterior and posterior rhinomanometry (< 3.0 cmH20•L-1•s).
Exclusion Criteria:
- recent surgery involving the upper airways,
- central apnoeas more than three per hour or five percent of total apnoeas,
- total sleep time during polysomnographies less than three hours,
- current treatment with nasal decongestants and topical steroids, and
- upper or lower respiratory tract disease, including a history of nasal allergy, and
- smoking.
Sites / Locations
- Centre of Sleep Disorders
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
nasal spray with tramazoline and dexamethazone
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Apnoea-hypopnoea index
After baseline assessment and randomization first group will undergo a one-week therapy with nasal tramazoline-dexamethazone, while second group will undergo a one-week therapy with nasal placebo. The second assessment will take place at the end of one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next first group will undergo a one-week therapy with nasal placebo, while second group will undergo a one-week therapy with nasal tramazoline-dexamethazone. Fourth assessment will then follow.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01601509
Brief Title
Nasal Tramazoline and Dexamethazone in Obstructive Sleep Apnea (OSA) Patients Tramazoline and
Acronym
NTD
Official Title
Randomized Placebo-controlled Cross-over Trial of the Effect of Nasal Tramazoline With Dexamethasone in Obstructive Sleep Apnoea Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Athens
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Nasal resistance presents considerable variations during night[8]. Additionally, Oral and oro-nasal breathing epochs exhibit strong correlation with the number of apnoea/hypopnoeas [7].The hypothesis that the present study aims to test is whether the pharmacological prevention of increased nasal resistance during night could alter breathing route pattern and lead to a decrease in the number of apnoea/hypopnoeas in OSA patients with normal nasal resistance.
Detailed Description
Nasal obstruction impairs sleep quality and may predispose to snoring and obstructive sleep apnoea (OSA) [1]. Indeed, in healthy subjects, experimental nasal occlusion has been shown to elicit obstructive apnoeas [2]. Additionally, in patients with OSA nasal obstruction is considered a risk factor for the development of OSA [3].
Despite the relationship between nasal obstruction and OSA, the therapeutic effect of improving nasal airway patency on OSA severity remains a point of conjecture [4]. In fact, administration of intranasal corticosteroids has been shown to improve sleepiness and reduce the apnoea/hypopnoea index (AHI) in patients with OSA and rhinitis [5], whereas in OSA patients with nasal obstruction the use of topical decongestants, external nasal dilators and nasal surgery has provided equivocal results [6].
The present authors have demonstrated a strong correlation between apnoea-hypopnoea index and oral/oro-nasal breathing epochs in patients with OSA and normal nasal resistance [7]. Additionally, Kohler et al [8] have shown that nasal resistance may increase during sleep reflecting substantial variability. Therefore, it is plausible to hypothesize that OSA patients presenting with normal nasal resistance when they are awake may demonstrate increased nocturnal nasal resistance during sleep that may predispose to oral/oro-nasal breathing and elicit apnoea/hypopnoeas. Prevention of nocturnal nasal obstruction in such OSA patients may decrease oral/oro-nasal breathing and eventually be beneficial for OSA by decreasing apnoea/hypopnoeas. Thus, the present study aims to investigate whether the pharmacological prevention of nasal obstruction could alter breathing route pattern and lead to a decrease in the number of apnoea/hypopnoeas in OSA patients with normal nasal resistance.
The study will include two nasal treatment options. Firstly, a combination of a nasal decongestant (tramazoline) with a nasal corticosteroid (dexamethazone). Tramazoline (imidazoline derivative) is a nasal decongestant, which attains its maximal effect between 30 and 210 min after application [9], while nasal dexamethasone can attenuate nasal inflammation associated with OSA [10]. Secondly, sodium chloride (0.9% solution).
OSA patients (AHI>10 events/h) with normal nasal resistance measured in seated and supine position with active anterior and posterior rhinomanometry (<3.0 cmH20•L-1•s) will be recruited. Exclusion criteria will be considered: 1) recent surgery involving the upper airways, 2) central apnoeas more than three per hour or five percent of total apnoeas, 3) total sleep time during polysomnographies less than three hours, 4) current treatment with nasal decongestants and topical steroids, and 5) upper or lower respiratory tract disease, including a history of nasal allergy, and 6) smoking.
A randomized double-blind, placebo-controlled, cross-over design will be used (Figure 1). Every patient will undergo four assessments which will take place 24-48 hours after each treatment arm. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow.
Figure 1. Study design
First group: one First group: one week nasal week nasal placebo tramazoline with dexamethazone
2 weeks washout period
Second group: one Second group: one week nasal placebo week nasaltramazoline with dexamethazone
First Assessment Second Assessment Third Assessment Fourth Assessment
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
nasal spray with tramazoline and dexamethazone
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Nasal tramazoline with dexamethazone
Intervention Description
Every patient will undergo four assessments. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow.
Intervention Type
Drug
Intervention Name(s)
Nasal placebo
Intervention Description
Every patient will undergo four assessments. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow.
Primary Outcome Measure Information:
Title
Apnoea-hypopnoea index
Description
After baseline assessment and randomization first group will undergo a one-week therapy with nasal tramazoline-dexamethazone, while second group will undergo a one-week therapy with nasal placebo. The second assessment will take place at the end of one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next first group will undergo a one-week therapy with nasal placebo, while second group will undergo a one-week therapy with nasal tramazoline-dexamethazone. Fourth assessment will then follow.
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
OSA patients (AHI > 10 events/h), and
normal nasal resistance measured in seated and supine position with active anterior and posterior rhinomanometry (< 3.0 cmH20•L-1•s).
Exclusion Criteria:
recent surgery involving the upper airways,
central apnoeas more than three per hour or five percent of total apnoeas,
total sleep time during polysomnographies less than three hours,
current treatment with nasal decongestants and topical steroids, and
upper or lower respiratory tract disease, including a history of nasal allergy, and
smoking.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioannis Koutsourelakis, MD
Organizational Affiliation
University of Athens
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre of Sleep Disorders
City
Athens
Country
Greece
12. IPD Sharing Statement
Citations:
PubMed Identifier
23397296
Citation
Koutsourelakis I, Minaritzoglou A, Zakynthinos G, Vagiakis E, Zakynthinos S. The effect of nasal tramazoline with dexamethasone in obstructive sleep apnoea patients. Eur Respir J. 2013 Oct;42(4):1055-63. doi: 10.1183/09031936.00142312. Epub 2013 Feb 8.
Results Reference
derived
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Nasal Tramazoline and Dexamethazone in Obstructive Sleep Apnea (OSA) Patients Tramazoline and
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