Pilot Randomized Trial of the Effect of Wireless Telemonitoring on Compliance and Treatment Efficacy in Obstructive Sleep Apnea

Abstract

Background Obstructive sleep apnea (OSA) is a prevalent and serious medical condition characterized by repeated complete or partial obstructions of the upper airway during sleep and is prevalent in 2% to 4% of working middle-aged adults. Nasal continuous positive airway pressure (CPAP) is the gold-standard treatment for OSA. Because compliance rates with CPAP therapy are disappointingly low, effective interventions are needed to improve CPAP compliance among patients diagnosed with OSA.Objective The aim was to determine whether wireless telemonitoring of CPAP compliance and efficacy data, compared to usual clinical care, results in higher CPAP compliance and improved OSA outcomes.Methods45 patients newly diagnosed with OSA were randomized to either telemonitored clinical care or usual clinical care and were followed for their first 2 months of treatment with CPAP therapy. CPAP therapists were not blinded to the participants’ treatment group.Results20 participants in each group received the designated intervention. Patients randomized to telemonitored clinical care used CPAP an average of 4.1 ± 1.8 hours per night, while the usual clinical care patients averaged 2.8 ± 2.2 hours per night (P = .07). Telemonitored patients used CPAP on 78% ± 22% of the possible nights, while usual care patients used CPAP on 60% ± 32% of the nights (P = .07). No statistically significant differences between the groups were found on measures of CPAP efficacy, including measures of mask leak and the Apnea-Hypopnea Index. Patients in the telemonitored group rated their likelihood to continue using CPAP significantly higher than the patients in the usual care group. Patients in both groups were highly satisfied with the care they received and rated themselves as “not concerned” that their CPAP data were being wirelessly monitored.Conclusions Telemonitoring of CPAP compliance and efficacy data and rapid use of those data by the clinical sleep team to guide the collaborative (ie, patient and provider) management of CPAP treatment is as effective as usual care in improving compliance rates and outcomes in new CPAP users. This study was designed as a pilot—larger, well-powered studies are necessary to fully evaluate the clinical and economic efficacy of telemonitoring for this population.

A Bayesian cost-effectiveness analysis of a telemedicine-based strategy for the management of sleep apnoea: a multicentre randomised controlled trial

“…Other telemedicine interventions, such as televisits, improved CPAP adherence in a small group of non-compliant OSA patients 16. Nevertheless, other studies have not found any positive effects 17 18. In summary, the results vary widely, and most studies were single-centre with low levels of CPAP compliance and small sample sizes.…”

Does remote monitoring change OSA management and CPAP adherence?

“…In this study, patients assigned to wireless TM used CPAP an average of 4.1 ± 1.8 h/night and 78 ± 22% of the nights. Patients assigned to the standard care group used CPAP an average 2.8 ± 2.2 h/night and 60 ± 32% of the nights, but the difference in CPAP usage between these two groups did not reach statistical significance …”

“…This kind of remote CPAP TM is now available in many countries but only limited data are available regarding its influence on CPAP adherence. A first pilot study in 45 patients showed a trend toward increasing CPAP usage (4.1 ± 1.8 vs 2.8 ± 2.2, P < 0.07, in the TM and the control group, respectively) . This proof of concept randomized controlled trial was certainly underpowered to reach significance but provided a rationale for conducting larger clinical and cost‐effectiveness trials.…”

A systematic review of CPAP adherence across age groups: Clinical and empiric insights for developing CPAP adherence interventions

“…Recently, several investigators have applied telecommunications methods such as computerized telephone systems (65–68) and/or wireless telemonitoring (69) or computerized informational systems (70) to influence patients’ use of CPAP. DeMolles’ group first tested a telephone-linked communication device (TLC) plus usual care compared with usual care alone among CPAP- naïve patients with severe OSA (15 participants per group).…”

“…(66) Stepnowsky (69) examined the effect of telemonitoring CPAP use with clinical pathway-defined responses to a priori defined nonadherence while Taylor (70) tested the effect of a computer-based “Health Buddy” that provided internet-based information, support and feedback for common challenges with CPAP. Both identified no statistical differences between intervention and control groups for CPAP adherence.…”