Nasal Decongestion and Obstructive Sleep Apnea

University of Zurich (UZH)

Status and phase: Completed; Phase 4

Conditions: Obstructive Sleep Apnea Syndrome; Rhinitis

Treatments: Drug: xylometazoline

Study type: Interventional

Funder types: Other

Identifiers

NCT00630474

EK-825

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

nasal application of xylometazoline

Treatment:

Drug: xylometazoline

2

Placebo Comparator group

Description:

nasal application of placebo

Treatment:

Drug: xylometazoline