OBJECTIVE: To assess the efficacy of an over-the-counter mechanical nasal dilator during sleep in pregnant women with nasal congestion. STUDY DESIGN: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. RESULTS: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). CONCLUSION: Use of this drug-free external nasal dilator improved the ease of breathing among patients with pregnancy-related nocturnal congestion.
RCT Entities:
OBJECTIVE: To assess the efficacy of an over-the-counter mechanical nasal dilator during sleep in pregnant women with nasal congestion. STUDY DESIGN: 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. RESULTS: 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). CONCLUSION: Use of this drug-free external nasal dilator improved the ease of breathing among patients with pregnancy-related nocturnal congestion.
Authors: Sarah K Wise; Sandra Y Lin; Elina Toskala; Richard R Orlandi; Cezmi A Akdis; Jeremiah A Alt; Antoine Azar; Fuad M Baroody; Claus Bachert; G Walter Canonica; Thomas Chacko; Cemal Cingi; Giorgio Ciprandi; Jacquelynne Corey; Linda S Cox; Peter Socrates Creticos; Adnan Custovic; Cecelia Damask; Adam DeConde; John M DelGaudio; Charles S Ebert; Jean Anderson Eloy; Carrie E Flanagan; Wytske J Fokkens; Christine Franzese; Jan Gosepath; Ashleigh Halderman; Robert G Hamilton; Hans Jürgen Hoffman; Jens M Hohlfeld; Steven M Houser; Peter H Hwang; Cristoforo Incorvaia; Deborah Jarvis; Ayesha N Khalid; Maritta Kilpeläinen; Todd T Kingdom; Helene Krouse; Desiree Larenas-Linnemann; Adrienne M Laury; Stella E Lee; Joshua M Levy; Amber U Luong; Bradley F Marple; Edward D McCoul; K Christopher McMains; Erik Melén; James W Mims; Gianna Moscato; Joaquim Mullol; Harold S Nelson; Monica Patadia; Ruby Pawankar; Oliver Pfaar; Michael P Platt; William Reisacher; Carmen Rondón; Luke Rudmik; Matthew Ryan; Joaquin Sastre; Rodney J Schlosser; Russell A Settipane; Hemant P Sharma; Aziz Sheikh; Timothy L Smith; Pongsakorn Tantilipikorn; Jody R Tversky; Maria C Veling; De Yun Wang; Marit Westman; Magnus Wickman; Mark Zacharek Journal: Int Forum Allergy Rhinol Date: 2018-02 Impact factor: 3.858
Authors: Barry Krakow; Dominic Melendrez; Brandy Sisley; Teddy D Warner; Jessica Krakow; Lisa Leahigh; Sam Lee Journal: Sleep Breath Date: 2006-03 Impact factor: 2.816
Authors: Asif Khalid; Christopher Thomas; Michael Kingsley; Kishore Vipperla; Jeffrey Dueker; Christianna Kreiss; Anna Evans Phillips; Rohit Das; Kenneth Fasanella; James Ibinson Journal: Endosc Int Open Date: 2022-09-14