Nasal Tramazoline and Dexamethazone in Obstructive Sleep Apnea (OSA) Patients Tramazoline and

NCT01601509 | Completed

• 1 other identifier: UOA-123
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea Syndrome

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 4 weeks

Study Arms (2)

nasal spray with tramazoline and dexamethazone

ACTIVE COMPARATOR

Drug: Nasal tramazoline with dexamethazone

Placebo

PLACEBO COMPARATOR

Drug: Nasal placebo

Interventions

Nasal tramazoline with dexamethazone DRUG

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.

nasal spray with tramazoline and dexamethazone

Nasal placebo DRUG

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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Athens: lead

Study Sites (1)

Centre of Sleep Disorders

Athens, Greece

Location

Related Publications (1)

• 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.

  PMID: 23397296 DERIVED

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ioannis Koutsourelakis, MD

  University of Athens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: March 4, 2012
• First Posted: May 18, 2012
• Study Start: April 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 18, 2012

Record last verified: 2012-05

Locations

GR (1)