Original ArticleA convenient expiratory positive airway pressure nasal device for the treatment of sleep apnea in patients non-adherent with continuous positive airway pressure
Introduction
Continuous positive airway pressure (CPAP) is usually first-line treatment for obstructive sleep apnea (OSA) in adults [1], [2], [3]. But tolerability of CPAP devices is suboptimal and the degree of adherence among CPAP users is low [4], [5], [6]. The proportion of patients for whom CPAP is recommended who do not tolerate use of the device sufficiently to begin home treatment is not well established but is thought to be substantial. In studies using a criterion for adherence of at least 4 h per night, adherence rates are frequently less than 50% of CPAP users. Thus, alternative OSA management approaches are needed.
More than 25 years ago, expiratory positive airway pressure (EPAP) was reported to reduce the apnea index in patients with OSA, although the mechanism involved remains unclear [7]. A convenient, mechanical, disposable EPAP nasal device (Fig. 1) has recently been developed for the treatment of OSA (ProventTM Therapy; Ventus Medical, Inc., Belmont, CA). A small mechanical valve attaches over each naris with an adhesive collar to form a seal. The valve produces increased resistance during expiration with minimal resistance during inspiration. Expiratory resistance results in modest levels of EPAP and increased expiratory time, either or both of which may make the airway more resistant to collapse on subsequent inspiration. Early studies indicate that EPAP applied with this device using expiratory resistances of 50–110 cm H2O/l/s at a flow rate of 100 ml/s may be an effective treatment for some OSA patients [8], [9].
The objective of the current investigation was to evaluate tolerability, efficacy, and short-term adherence of this EPAP device in a sample of OSA patients who have either refused or reported minimal adherence with CPAP treatment.
Section snippets
Methods
Patients were recruited from the study site’s patient population and via media advertisement. Inclusion criteria included males and females at least 18 years old with current signs and symptoms of OSA who, within the past 5 years, had refused CPAP treatment, discontinued CPAP, or had been minimally adherent with CPAP, or defined as reported use less than 3 h per night. On screening/baseline PSG patients were required to have an AHI > 15, or AHI > 10 with evidence of excessive daytime sleepiness,
Participants
Fig. 2 shows the disposition of patients. Sixty-nine patients provided informed consent. Ten patients did not meet one or more inclusion/exclusion criteria at the screening office visit (nasal obstruction, 5; CPAP use >3 h per night or willing to reconsider CPAP, 3; insomnia, 2; OSA symptoms negligible following significant weight loss, 1; nasal decongestant use, 1) and 59 patients proceeded with home trial of EPAP. Fifty-eight of these patients reported prior attempt to use CPAP at home an
Discussion
The results of this study indicate that treatment with a convenient EPAP device is tolerated by 80% of patients with poor adherence to CPAP and improves OSA in 56% of patients based upon PSG2. Moreover, for patients meeting initial efficacy criteria, approximately 7 weeks of EPAP treatment resulted in improvement in clinical status as assessed by ESS and FOSQ. Mean ESS following treatment was in the normal range [13] and mean FOSQ was near normal [14]. This degree of improvement in ESS and FOSQ
Conflict of interest
The ICMJE Uniform Disclosure Form for Potential Conflicts of Interest associated with this article can be viewed by clicking on the following link: doi:10.1016/j.sleep.2010.06.011.
Acknowledgements
This investigator-initiated study was supported by a research grant from Ventus Medical Inc., Belmont, CA.
Dr. Walsh has received research support from Pfizer, Merck, Somaxon, Evotec, Actelion, Vanda, Neurogen, Sanofi-Aventis, Ventus, Respironics, and Jazz Pharmaceuticals. Dr. Walsh has provided consulting services to Pfizer, Sanofi-Aventis, Cephalon, Schering-Plough/Organon, Neurocrine, Takeda America, Actelion, Sepracor, Jazz, Respironics, Transcept, Neurogen, GlaxoSmithKline, Somaxon, Eli
References (18)
- et al.
An oral hypnotic medication does not improve continuous positive airway pressure compliance in men with obstructive sleep apnea
Chest
(2006 Nov) - et al.
Practice parameters for the use of continuous and bilevel positive airway pressure devices to treat adult patients with sleep-related breathing disorders
Sleep
(2006) - et al.
CTS sleep disordered breathing committee Canadian thoracic society guidelines: diagnosis and treatment of sleep disordered breathing in adults
Can Respir J
(2006) - et al.
Evidence-based recommendations for the assessment and management of sleep disorders in older persons
J Am Geriatr Soc
(2009) - et al.
Adherence to continuous positive airway pressure therapy: the challenge to effective treatment
Proc Am Thorac Soc
(2008) - et al.
Long-term compliance with continuous positive airway pressure in patients with obstructive sleep apnea
Can Respir J
(2008) - et al.
Long-term use of CPAP therapy for sleep apnea/hypopnea syndrome
Am J Respir Crit Care Med
(1999) - et al.
Effects of expiratory positive airway pressure on sleep-induced respiratory abnormalities in patients with hypersomnia–sleep apnea syndrome
Am Rev Respir Dis
(1983) - et al.
A pilot evaluation of a nasal expiratory resistance device for the treatment of obstructive sleep apnea
J Clin Sleep Med
(2008)
Cited by (22)
Considering the Role of Adherence in New and Emerging Sleep Treatments
2021, Sleep Medicine ClinicsCitation Excerpt :In the 119 patients who received 3 months of treatment, the device was worn the entire night for median 88.2% (67.5, 96.4) of nights and experienced a 43% reduction in the AHI. Similarly, in a study by Walsh and colleagues,60 a dropout rate of 11/59 patients was reported. Of the 24 participants randomized to receive treatment device, use of 92% to 97% of sleep time was reported over a 5-week period as well as experiencing a 45% reduction in their AHI.
Efficacy and safety assessment of expiratory positive airway pressure (EPAP) mask for OSAHS therapy
2019, Auris Nasus LarynxCitation Excerpt :The device creates enough pressure during expiratory with only several holes open, which makes the upper airway keep unobstructed. Multiple researches suggested that the nasal EPAP were effective for OSASH treatment.[7–9] Based on the theory and the fact mentioned above about the EPAP therapy, we have reasons to believe that the independent EPAP treatment is available for curing OSAHS as well as making up for the shortage of the relevant therapies at present.
New perspectives in the treatment of obstructive sleep apnea-hypopnea syndrome
2017, Revista Colombiana de AnestesiologiaAlternative therapies for obstructive sleep apnea
2013, Sleep Medicine ClinicsCitation Excerpt :No significant predictor of response could be elucidated. In another trial, by Walsh and colleagues,11 59 patients with OSA (AHI>15 or AHI>10 with OSA symptoms) who had not tolerated CPAP therapy were single-blindedly offered Provent EPAP devices with 2 different resistances (50 cm H2O/s/L [R50] and 80 cm H2O/s/L [R80] at a flow of 100 mL/s). Patients were allowed to chose a preferred device after trying both (24 patients chose R50 and 15 patients chose R80) or were assigned a device if they had no preference.
A multicenter evaluation of oral pressure therapy for the treatment of obstructive sleep apnea
2013, Sleep MedicineCitation Excerpt :Medical inclusion criteria included the necessity of nasal patency, as demonstrated with a PNIF of at least 75 L per minute. The requirement for nasal patency was a consideration, given the need to breathe nasally while on the device, and is similar to the requirements used in studies evaluating nasal CPAP [19–21] or expiratory PAP via a nasal valve device [22–25]. Of the 146 subjects in the safety cohort, 60 were screened out based on a priori criteria of not being able to demonstrate more than 4 h of sleep with an adequate mouth vacuum in an at-home screening night.