Nasal Decongestion and Obstructive Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-01-31

Study Completion Date

2005-04-30

Brief Summary

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Whether impaired nasal breathing contributes to sleep related breathing disturbances has not been known. Therefore, the purpose of the study is to compare the effect of xylometazoline, a drug that decongests the nasal mucosa when applied locally, with placebo in terms of sleep and nocturnal breathing and daytime performance.

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Detailed Description

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Conditions

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Obstructive Sleep Apnea Syndrome Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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1

nasal application of xylometazoline

Group Type ACTIVE_COMPARATOR

xylometazoline

Intervention Type DRUG

xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril

2

nasal application of placebo

Group Type PLACEBO_COMPARATOR

xylometazoline

Intervention Type DRUG

xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril

Interventions

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xylometazoline

xylometazoline (0.1 % solution, 3 drops, 0.15 mg) in each nostril

Intervention Type DRUG

Other Intervention Names

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Otrivin

Eligibility Criteria

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Inclusion Criteria

* Obstructive sleep apnea syndrome (excessive sleepiness, apnea/hypopnea index \>10/h)
* Chronic nasal congestion (complaint of impaired nasal breathing that interfered with subjective sleep quality on at least 3 nights per week during at least the last 3 months)

Exclusion Criteria

* Nasal surgery within the last 6 months
* Current treatment with nasal decongestants or topical steroids
* Sleep disorders other than obstructive sleep apnea
* Internal medical or psychiatric disorders that interfered with sleep

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No