A Pilot Randomized-Controlled Trial on the Effect of CPAP Treatment on Glycemic Control in Gestational Diabetes: Study Design and Methods

Sushmita Pamidi, Sara J Meltzer, Natasha Garfield, Lorraine Lavigne, Allen Olha, Ahamed Khalyfa, Andrea Benedetti, Geneviève Tremblay, Robert Gagnon, Evelyne Rey, Kaberi Dasgupta, R John Kimoff, Sushmita Pamidi, Sara J Meltzer, Natasha Garfield, Lorraine Lavigne, Allen Olha, Ahamed Khalyfa, Andrea Benedetti, Geneviève Tremblay, Robert Gagnon, Evelyne Rey, Kaberi Dasgupta, R John Kimoff

Abstract

Background: Gestational diabetes (GDM) is associated with adverse short- and long-term maternal and fetal outcomes. Observational data support a link between sleep-disordered breathing (SDB) during pregnancy and GDM. However, it is unknown whether treatment of SDB with continuous positive airway pressure (CPAP) improves glucose control in this patient population. In addition, CPAP adherence and feasibility as a treatment option in pregnancy is unknown. This pilot randomized, controlled trial aims to primarily determine the feasibility of CPAP treatment in pregnant women with SDB and GDM. This study is also investigating the effect of SDB treatment on 24-h glucose profiles as an exploratory outcome. Objectives: To describe the study methodology in this ongoing study of pregnant women with GDM and SDB. Patients and Methods: Pregnant women with GDM and SDB defined by apnea-hypopnea index (AHI) ≥10 (Chicago Scoring Criteria) on level 2 polysomnography are randomized to either auto titrating CPAP (experimental group) or a nasal dilator strip (control group) until delivery. The primary outcome, objectively-assessed adherence to CPAP, is measured over the course of the treatment period using device-specific software. Recruitment and retention rates will be calculated to assess the feasibility for planning future trials. Twenty-four hour glucose profiles are measured over a 72-h period using the continuous glucose monitoring (CGM) system, before and after the intervention. Conclusion: The results of this study will be highly informative to determine whether CPAP is a feasible treatment for pregnant women with GDM and SDB, a specialized population at risk for substantial comorbidity. The trial results will ultimately be useful in planning future SDB treatment trials in pregnancy and GDM. The study is registered on clinicaltrials.gov (NCT02245659).

Keywords: CPAP (continuous positive airway pressure); diabetes; gestational diabetes; pregnancy; sleep apnea.

Figures

Figure 1
Figure 1
The trial protocol involves a baseline evaluation that initially confirms the diagnosis of gestational diabetes (GDM). This testing usually takes place between 24 and 28 weeks of gestational age. During the baseline visit, participants wear an Armband, consisting of an accelerometer, for 1 week in order monitor activity levels and sleep-wake patterns. Insertion of a continuous glucose monitoring (CGM) device for 72 h takes place at this visit. Within 1–2 weeks, a home sleep study to screen for sleep-disordered breathing (SDB) is organized. If participants are eligible for the study, randomization to either auto-titrating continuous positive airway pressure (CPAP) or nasal dilator strip (control group) takes place. Participants follow-up with the study nurse every 2 weeks to verify adherence to therapy and complete study measurements. Post-partum, participants are invited back for a repeat sleep study ~12 weeks after the study is completed and also complete an oral glucose tolerance test as part of routine follow-up with the endocrinologist.

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