Randomized placebo-controlled trial of pantoprazole for daytime sleepiness in GERD and obstructive sleep disordered breathing.
OBJECTIVE
To determine the efficacy of pantoprazole therapy for daytime somnolence, psychomotor vigilance, and quality of life in patients with mild-moderate obstructive sleep disordered breathing (OSDB) and gastroesophageal reflux disease (GERD).


METHODS
Randomized, double-blind, placebo-controlled crossover trial.


METHODS
Sixty patients with daytime sleepiness, mild-moderate OSDB and GERD were randomly assigned a 2-week treatment with pantoprazole 40 mg or placebo followed by a 2-week washout period and crossover respectively to 2-week treatment with placebo or pantoprazole. Outcomes included Epworth Sleepiness Score (ESS), sleep-related quality-of-life (FOSQ), and reaction time.


RESULTS
With pantoprazole, patients reported statistically significantly greater improvement of overall reflux symptoms (P = 0.0003) and in ESS (P = 0.04). A significant improvement was noted in FOSQ for both treatments with a trend toward greater improvement with pantoprazole (P = 0.058). No improvement in reaction times was observed.


CONCLUSIONS
Patients with coexistent GERD and OSDB noted significant improvement in daytime sleepiness after treatment with pantoprazole over placebo likely related to a reduction in nocturnal reflux-related arousals.
Suurna
Maria V
MV
Department of Otolaryngology, Head and Neck Surgery, University of Cincinnati College of Medicine, Cincinnati, OH 45267-0528, USA. Maria.Suurna@uc.edu <Maria.Suurna@uc.edu>
Welge
Jeff
J
Surdulescu
Victoria
V
Kushner
Jonathan
J
Steward
David L
DL
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000627:therapeutic use*; D000897:Anti-Ulcer Agents / Q000627:therapeutic use*; D001143:Arousal / Q000187:drug effects; D018592:Cross-Over Studies; D006970:Disorders of Excessive Somnolence / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D005764:Gastroesophageal Reflux / Q000150:complications / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077402:Pantoprazole; D010919:Placebos; D011788:Quality of Life; D012891:Sleep Apnea Syndromes / Q000188:drug therapy* / Q000209:etiology; D016896:Treatment Outcome; D014851:Wakefulness / Q000187:drug effects
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D000897:Anti-Ulcer Agents; D010919:Placebos; D000077402:Pantoprazole