Managing pregnancy-related nocturnal nasal congestion. The external nasal dilator

To assess the efficacy of an over-the-counter mechanical nasal dilator during sleep in pregnant women with nasal congestion.

Pregnant women with symptoms of nocturnal nasal congestion not attributed to allergies or "cold" symptoms were randomized in a double-blind manner to receive either a spring-loaded device or placebo device without a spring. Each patient assessed breathing and sleep quality for a three-day baseline and three-day treatment period. A 10-question diary was utilized to assess breathing, ease of falling asleep, sleep quality, and continuity and depth of sleep. Averaged scores for each question were computed for baseline and treatment periods, and differences were calculated. Statistical analyses were by the sign test, Fisher's exact test and Student's test.

Thirty-four (21%) of 160 screened patients were enrolled into the study; 24 (15%) completed the study. All agreed to being assigned to receive either the spring-loaded device (n = 12) or a placebo (n = 12) device. Responses to 8 of the 10 questions favored the former as compared with the placebo (P = .05, sign test). Moreover, patients treated with the spring-loaded device gave more favorable responses to the question, "Overall, compared with most nights, how easy was your breathing through-out last night?" (P = .02, t test).

Use of this drug-free external nasal dilator improved the ease of breathing among patients with pregnancy-related nocturnal congestion.