Efficacy of Omega-3 in Improving Sleep Quality of Healthcare Workers with Shiftwork Sleep Disorder: Phase III, Double-blind, Placebo-controlled Trial Study Protocol (SLEEP-O3 Trial)
Authors: Sequeira María Lucía ,   Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA, Ortiz Maria Isabel Bojorquez , de Faria Camila Bernardes , Yonekura Vitor Yukio , Gruber Aline Aparecida Lacerda , Assad Igor Malheiros , Peña Luciano Hurtano , Rudzevicius Lukas , Aguiar Marilia Ribeiro de Azevedo , Khater Ahmad G. A. , Londoño Agustín Pérez , Sawaf Bisher , Nam Dongwoo , Aguayo Francisco Espinoza , Dugar Franja , Gomes Guilherme de Araujo , Quinto Luis Angel Rivera , AlMuhanna Rawan Mohammad , Canizares Stalin , Scholl Vanesa ,   Universidad Francisco Marroquín, Ciudad de Guatemala, Guatemala,   Universidad Francisco Marroquín, Ciudad de Guatemala, Guatemala,   Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA,   Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA,   Universidade Federal de São Paulo, São Paulo, Brazil,   Emergency Department, Dávila Clinic, Santiago, Chile,   Department of Neurosurgery, Klinikum Chemnitz gGmbH, Chemnitz, Germany,   Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo, São Paulo, Brazil,   Faculty of Oral and Dental Medicine, Egyptian Russian University, Cairo, Egypt,   Division of Urologic Surgery, Beth Israel Deaconess Medical Center, Boston, MA, USA,   Department of Internal Medicine, Hamad Medical Hospital, Doha, Qatar,   Department of Acupuncture and Moxibustion Medicine, Kyung Hee University College of Korean Medicine, Seoul, Korea,   Medicine Faculty, Universidad del Desarrollo, Clinica Alemana, Santiago, Chile,   Department of Radiology and Nuclear Medicine, University Hospital Basel, Basel, Switzerland,   Hospital São Vicente de Paula, Passo Fundo, Brazil,   Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA,   Saudi Commission For Health Specialties, Riyadh, Saudi Arabia,   Harvard T. H Chan School of Public Health - ECPE - PPCR Program, Boston, MA, USA,   Conciencia Clinic, Neuquén, Argentina.
Published: July 2024

Introduction: Healthcare workers are especially vulnerable to sleep disturbances, including shift work sleep disorder (SWSD). Even though omega-3 supplementation has been studied to enhance sleep quality in different populations, there is lack of evidence to support its effectiveness in SWSD. This trial aims to evaluate this compound potential benefits towards health care personnel suffering from SWSD. Methods: This study protocol consists of a phase III, single-center, double-blind, placebo-controlled randomized clinical trial. Participants will receive sleep hygiene orientation in addition to either omega-3 dietary supplementation or placebo for 8 weeks. The primary outcome will be sleep quality as measured by the Pittsburgh Sleep Quality Index and one of the secondary outcomes would be actigraphy as a reliable sleep assessment. The sample size will be 136 subjects. Discussion: The importance of improving sleep quality of health care workers relies on its impact on their wellness, and on patient safety. Sleep deprivation and disorders are responsible for multiple workplace errors and worse health outcomes alike. This trial can help determine if omega-3 supplementation can contribute to ameliorate sleep disturbances in health care professionals.