Although there is increasing interest in the use of oral appliances to treat obstructive sleep apnea (OSA), the evidence base for this is weak. Furthermore, the precise mechanisms of action are uncertain. We aimed to systematically investigate the efficacy of a novel mandibular advancement splint (MAS) in patients with OSA. The sample consisted of 28 patients with proven OSA. A randomized, controlled three-period (ABB/BAA) crossover study design was used. After an acclimatization period, patients underwent three polysomnographs with either a control oral plate, which did not advance the mandible (A), or MAS (B), 1 wk apart, in either the ABB or BAA sequence. Complete response (CR) was defined as a resolution of symptoms and a reduction in Apnea/Hypopnea Index (AHI) to < 5/h, and partial response (PR) as a > or = 50% reduction in AHI, but remaining > or = 5/h. Twenty-four patients (19 men, 5 women) completed the protocol. Subjective improvements with the MAS were reported by the majority of patients (96%). There were significant improvements in AHI (30 +/- 2/h versus 14 +/- 2/h, p < 0.0001), MinSa(O(2)) (87 +/- 1% versus 91 +/- 1%, p < 0.0001), and arousal index (41 +/- 2/h versus 27 +/- 2/h, p < 0.0001) with MAS, compared with the control. The control plate had no significant effect on AHI and MinSa(O(2)). CR (n = 9) or PR (n = 6) was achieved in 62.5% of patients. The MAS is an effective treatment in some patients with OSA, including those patients with moderate or severe OSA.
Important health outcomes were similar after 1 month of optimal MAD and CPAP treatment in patients with moderate-severe OSA. The results may be explained by greater efficacy of CPAP being offset by inferior compliance relative to MAD, resulting in similar effectiveness. Clinical trial registered with https://www.anzctr.org.au (ACTRN 12607000289415).
Oral appliances (OA) have emerged as an alternative to continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA) treatment. The most commonly used OA reduces upper airway collapse by advancing the mandible (OAm). There is a strong evidence base demonstrating OAm improve OSA in the majority of patients, including some with more severe disease. However OAm are not efficacious for all, with approximately one-third of patients experiencing no therapeutic benefit. OAm are generally well tolerated, although short-term adverse effects during acclimatization are common. Long-term dental changes do occur, but these are for the most part subclinical and do not preclude continued use. Patients often prefer OAm to gold-standard CPAP treatment. Head-to-head trials confirm CPAP is superior in reducing OSA parameters on polysomnography; however, this greater efficacy does not necessarily translate into better health outcomes in clinical practice. Comparable effectiveness of OAm and CPAP has been attributed to higher reported nightly use of OAm, suggesting that inferiority in reducing apneic events may be counteracted by greater treatment adherence. Recently, significant advances in commercially available OAm technologies have been made. Remotely controlled mandibular positioners have the potential to identify treatment responders and the level of therapeutic advancement required in single night titration polysomnography. Objective monitoring of OAm adherence using small embedded temperature sensing data loggers is now available and will enhance clinical practice and research. These technologies will further enhance efficacy and effectiveness of OAm treatment for OSA.
IntroductionMany intensive care patients experience sleep disruption potentially related to noise, light and treatment interventions. The purpose of this study was to characterise, in terms of quantity and quality, the sleep of intensive care patients, taking into account the impact of environmental factors.MethodsThis observational study was conducted in the adult ICU of a tertiary referral hospital in Australia, enrolling 57 patients. Polysomnography (PSG) was performed over a 24-hour period to assess the quantity (total sleep time: hh:mm) and quality (percentage per stage, duration of sleep episode) of patients' sleep while in ICU. Rechtschaffen and Kales criteria were used to categorise sleep. Interrater checks were performed. Sound pressure and illuminance levels and care events were simultaneously recorded. Patients reported on their sleep quality in ICU using the Richards Campbell Sleep Questionnaire and the Sleep in Intensive Care Questionnaire. Data were summarised using frequencies and proportions or measures of central tendency and dispersion as appropriate and Cohen's Kappa statistic was used for interrater reliability of the sleep data analysis.ResultsPatients' median total sleep time was 05:00 (IQR: 02:52 to 07:14). The majority of sleep was stage 1 and 2 (medians: 19 and 73%) with scant slow wave and REM sleep. The median duration of sleep without waking was 00:03. Sound levels were high (mean Leq 53.95 dB(A) during the day and 50.20 dB(A) at night) and illuminance levels were appropriate at night (median <2 lux) but low during the day (median: 74.20 lux). There was a median 1.7 care events/h. Patients' mean self-reported sleep quality was poor. Interrater reliability of sleep staging was highest for slow wave sleep and lowest for stage 1 sleep.ConclusionsThe quantity and quality of sleep in intensive care patients are poor and may be related to noise, critical illness itself and treatment events that disturb sleep. The study highlights the challenge of quantifying sleep in the critical care setting and the need for alternative methods of measuring sleep. The results suggest that a sound reduction program is required and other interventions to improve clinical practices to promote sleep in intensive care patients.Trial registrationAustralian New Zealand clinical trial registry (http://www.anzctr.org.au/): ACTRN12610000688088.
The aim of this study was to evaluate the effect of a mandibular advancement splint (MAS) on daytime sleepiness and a range of other symptoms in obstructive sleep apnea (OSA). Using a randomized crossover design, patients received 4 weeks of treatment with MAS and a control device (inactive oral appliance), with an intervening 1-week washout. At the end of each treatment period, patients were reassessed by questionnaire, polysomnography, and multiple sleep latency test. Fifty-nine men and 14 women with a mean (+/- SD) age of 48 +/- 11 years and proven OSA experienced a significantly improved mean (+/- SEM) sleep latency on the multiple sleep latency test (10.3 +/- 0.5 versus 9.1 +/- 0.5 minutes, p = 0.01) and Epworth sleepiness scale score (7 +/- 1 versus 9 +/- 1, p < 0.0001) with the MAS compared with the control device after 4 weeks. The proportion of patients with normal subjective sleepiness was significantly higher with the MAS than with the control device (82 versus 62%, p < 0.01), but this was not so for objective sleepiness (48 versus 34%, p = 0.08). Other OSA symptoms were controlled in significantly more patients with the MAS than with the control device. MAS therapy improves a range of symptoms associated with OSA.
Oral appliance therapy for obstructive sleep apnea over 4 weeks results in a reduction in blood pressure, similar to that reported with continuous positive airway pressure therapy.
BackgroundThe mechanisms by which mandibular advancement splints (MAS) improve obstructive sleep apnoea (OSA) are not well understood. This study aimed to evaluate the mechanism of action of MAS by assessing their effect on upper airway structure in patients with OSA. Methods Patients were recruited from a sleep disorders clinic for treatment with a custom-made MAS. MRI of the upper airway was performed during wakefulness in the supine position, with and without the MAS.
Craniofacial factors and obesity contribute differentially to OSA in Caucasian and Chinese patients. For the same degree of OSA severity, Caucasians were more overweight, whereas Chinese exhibited more craniofacial bony restriction.
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