Mean Number Of Nights Research Articles

Feasibility and Acceptability of Wearable Sleep Electroencephalogram Device Use in Adolescents: Observational Study.

BackgroundAdolescence is an important life stage for the development of healthy behaviors, which have a long-lasting impact on health across the lifespan. Sleep undergoes significant changes during adolescence and is linked to physical and psychiatric health; however, sleep is rarely assessed in routine health care settings. Wearable sleep electroencephalogram (EEG) devices may represent user-friendly methods for assessing sleep among adolescents, but no studies to date have examined the feasibility and acceptability of sleep EEG wearables in this age group.ObjectiveThe goal of the research was to investigate the feasibility and acceptability of sleep EEG wearable devices among adolescents aged 11 to 17 years.MethodsA total of 104 adolescents aged 11 to 17 years participated in 7 days of at-home sleep recording using a self-administered wearable sleep EEG device (Zmachine Insight+, General Sleep Corporation) as well as a wristworn actigraph. Feasibility was assessed as the number of full nights of successful recording completed by adolescents, and acceptability was measured by the wearable acceptability survey for sleep. Feasibility and acceptability were assessed separately for the sleep EEG device and wristworn actigraph.ResultsA total of 94.2% (98/104) of adolescents successfully recorded at least 1 night of data using the sleep EEG device (mean number of nights 5.42; SD 1.71; median 6, mode 7). A total of 81.6% (84/103) rated the comfort of the device as falling in the comfortable to mildly uncomfortable range while awake. A total of 40.8% (42/103) reported typical sleep while using the device, while 39.8% (41/103) indicated minimal to mild device-related sleep disturbances. A minority (32/104, 30.8%) indicated changes in their sleep position due to device use, and very few (11/103, 10.7%) expressed dissatisfaction with their experience with the device. A similar pattern was observed for the wristworn actigraph device.ConclusionsWearable sleep EEG appears to represent a feasible, acceptable method for sleep assessment among adolescents and may have utility for assessing and treating sleep disturbances at a population level. Future studies with adolescents should evaluate strategies for further improving usability of such devices, assess relationships between sleep EEG–derived metrics and health outcomes, and investigate methods for incorporating data from these devices into emerging digital interventions and applications.Trial RegistrationClinicalTrials.gov NCT03843762; https://clinicaltrials.gov/ct2/show/NCT03843762

Thoracoscopy and talc poudrage compared with intercostal drainage and talc slurry infusion to manage malignant pleural effusion: the TAPPS RCT.

There are around 40,000 new cases of malignant pleural effusion in the UK each year. Insertion of talc slurry via a chest tube is the current standard treatment in the UK. However, some centres prefer local anaesthetic thoracoscopy and talc poudrage. There is no consensus as to which approach is most effective. This trial tested the hypothesis that thoracoscopy and talc poudrage increases the proportion of patients with successful pleurodesis at 3 months post procedure, compared with chest drain insertion and talc slurry. This was a multicentre, open-label, randomised controlled trial with embedded economic evaluation. Follow-up took place at 1, 3 and 6 months. This trial was set in 17 NHS hospitals in the UK. A total of 330 adults with a confirmed diagnosis of malignant pleural effusion needing pleurodesis and fit to undergo thoracoscopy under local anaesthetic were included. Those adults needing a tissue diagnosis or with evidence of lung entrapment were excluded. Allocation took place following minimisation with a random component, performed by a web-based, centralised computer system. Participants in the control arm were treated with a bedside chest drain insertion and 4 g of talc slurry. In the intervention arm, participants underwent local anaesthetic thoracoscopy with 4 g of talc poudrage. The primary outcome measure was pleurodesis failure at 90 days post randomisation. Secondary outcome measures included mortality and patient-reported symptoms. A cost-utility analysis was also performed. A total of 166 and 164 patients were allocated to poudrage and slurry, respectively. Participants were well matched at baseline. For the primary outcome, no significant difference in pleurodesis failure was observed between the treatment groups at 90 days, with rates of 36 out of 161 (22%) and 38 out of 159 (24%) noted in the poudrage and slurry groups, respectively (odds ratio 0.91, 95% confidence interval 0.54 to 1.55; p = 0.74). No differences (or trends towards difference) were noted in adverse events or any of the secondary outcomes at any time point, including pleurodesis failure at 180 days [poudrage 46/161 (29%), slurry 44/159 (28%), odds ratio 1.05, 95% confidence interval 0.63 to 1.73; p = 0.86], mean number of nights in hospital over 90 days [poudrage 12 nights (standard deviation 13 nights), slurry 11 nights (standard deviation 10 nights); p = 0.35] and all-cause mortality at 180 days [poudrage 66/166 (40%), slurry 68/164 (42%); p = 0.70]. At £20,000 per quality-adjusted life-year gained, poudrage would have a 0.36 probability of being cost-effective compared with slurry. Entry criteria specified that patients must be sufficiently fit to undergo thoracoscopy, which may make the results less applicable to those patients presenting with a greater degree of frailty. Furthermore, the trial was conducted on an open-label basis, which may have influenced the results of patient-reported measures. The TAPPS (evaluating the efficacy of Thoracoscopy And talc Poudrage versus Pleurodesis using talc Slurry) trial has robustly demonstrated that there is no additional clinical effectiveness or cost-effectiveness benefit in performing talc poudrage at thoracoscopy over bedside chest drain and talc slurry for the management of malignant pleural effusion. Current Controlled Trials ISRCTN47845793. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 26. See the NIHR Journals Library website for further project information.

Effectiveness of Road Mitigation for Common Toads (Bufo bufo) in the Netherlands

Roads and traffic may have major impacts on amphibian populations, primarily as a result of amphibian road mortality. A variety of measures have been developed to prevent road mortality of amphibians, such as the construction of fences to keep the animals off the road and amphibian tunnels to provide them a safe passage. We carried out a capture-mark-recapture study to evaluate the performance of two tunnels and permanent drift fences for common toads at a local road in the Netherlands. We found that of the marked toads only 31% used the tunnels to cross the road. We assessed four possible explanations for the fact that a proportion of the toads did not use the tunnels: for toad groups that used the tunnels, as compared to toad groups that did not use the tunnels, (1) the mean distance between the location of first capture and the nearest tunnel was significantly smaller; (2) the mean movement distance along the fence was significantly larger; (3) the number of toad groups that walked in the wrong direction after encountering the drift fence was lower; (4) the mean number of nights between first and last capture of the toad group was significantly higher. Over all study years 28% of the migrating toads-marked and unmarked-that attempted to cross the road ended up on the road pavement, despite the mitigation. Migrating population numbers decreased with about 75% after the mitigation measures were installed. We emphasize that better baseline studies on where toads cross before mitigation and improved knowledge on effects of tunnel design and the distances the animals move along a drift fence are vital to mitigate road impacts properly and maintain viable toad populations. We recommend to base tunnel densities on the mean movement distance of the toads that move only small distances and spent relatively little time along the drift fence, install drift fences that go well beyond the location where toads cross the road, take appropriate measures at entrance roads and at fence ends and consider alternatives to tunnels and fences, such as the creation of breeding waters on both sides of the road.

Evaluation of the efficacy of a dedicated table to improve CPAP adherence in children: a pilot study

ObjectiveOnly a few studies have addressed strategies to improve continuous positive airway pressure (CPAP) adherence in children with obstructive sleep apnea. The aim of our study was to assess the efficacy of a table based on token economy to improve CPAP adherence. MethodsA table was proposed to children nonadherent to CPAP (<3 h per night of CPAP use), eight days after CPAP initiation (D8). The child has to fill the table on a daily basis with green (I used my CPAP this night) or red (I did not use my CPAP) tokens. Objectives of CPAP use and rewards were decided between the child and their parents. An assessment of CPAP adherence was performed one month after initiation of table filling (M1) and compared to CPAP adherence at D8, and to data of adherent children. ResultsData of six nonadherent and nine adherent children were gathered (age 5 ± 5 vs. 5 ± 3 years, p = 0.953; apnea−hypopnea index 20 ± 15 vs. 25 ± 16 events/h, p = 0.550, respectively). Mean CPAP adherence at D8 was 4.7 ± 1.6 nights/wk and 1h00 ± 0h33 in the nonadherent children, vs. 6.9 ± 0.4 nights/wk and 7h16 ± 1h51 in the adherent group (p < 0.01). The mean number of nights per week at M1 was 6.4 ± 0.6 nights in nonadherent children (p = 0.086), and was equivalent to that in adherent children (6.8 ± 0.6 nights, p = 0.126). Mean adherence at M1 increased to 4h31 ± 1h12 in non-adherent children (p < 0.001), but was still lower when compared to that in adherent children (7h27 ± 2h00, p = 0.007). ConclusionThe study findings imply that use of a simple table by a child appears to be effective in improving CPAP adherence at one month.

Objectively measured night-to-night sleep variations are associated with body composition in very elderly women.

This cross-sectional study examined the association between objectively measured sleep patterns and body composition in very elderly community-dwelling women. Participants included 191 community-dwelling adults aged ≥ 80 years (mean age: 83.4 ± 2.6 years; age range: 80-92 years). Sleep and physical activity were monitored via accelerometer (ActiGraph GT3X+) during at least five consecutive 24-h periods. Night-to-night sleep pattern variability across all nights of recording was assessed using standard deviations (SDs). Body composition was assessed using dual-energy X-ray absorptiometry. Simple and multivariable linear regression analyses were performed. The mean number of nights with usable actigraphy data was 7.3 ± 1.3. On average, participants went to bed at 22:57 hours (SD: 1.11 h) and rose from bed at 6:27 hours (SD: 1.01 h). Night-to-night bedtime, sleep duration and sleep timing mid-point variations correlated slightly with the percentage body fat and percentage lean mass (P < 0.05). Multiple linear regression analysis revealed significant associations of night-to-night bedtime variations and inconsistent sleep-wake patterns with all body composition indices after adjusting for potential confounding factors, including mean nightly sleep duration, self-reported nap duration and daily physical activity. After further adjusting for night-to-night wake time, sleep timing mid-point and sleep duration variations, greater bedtime variability remained associated significantly with all body composition indices except lean/fat mass ratio. Inconsistent sleep-wake patterns were associated independently with an increased fat mass and decreased lean mass among very elderly women. These findings suggest that in most elderly individuals, sleep patterns might be an important modifiable factor associated with obesity and sarcopenia development.

Prolonged-release melatonin for insomnia &amp;ndash; an open-label long-term study of efficacy, safety, and withdrawal

BackgroundProlonged-release melatonin (PRM) 2 mg is indicated for insomnia in patients aged 55 years and older. A recent double-blind placebo-controlled study demonstrated 6-month efficacy and safety of PRM in insomnia patients aged 18–80 and lack of withdrawal and rebound symptoms upon discontinuation.ObjectiveTo investigate the efficacy, safety, and withdrawal phenomena associated with 6–12 months PRM treatment.MethodsData from a prospective 6–12-month open-label study of 244 community dwelling adults with primary insomnia, who had participated in a placebo-controlled, double-blind dose-ranging trial of PRM. Patients received PRM nightly, followed by a 2-week withdrawal period. Main outcome measures were patient-reported sleep quality ratings (diary), adverse events, vital signs, and laboratory tests recorded at each visit, and withdrawal symptoms (CHESS-84 [Check-list Evaluation of Somatic Symptoms]). Nocturnal urinary 6-sulfatoxymelatonin excretion, a measure of the endogenous melatonin production, was assessed upon discontinuing long-term PRM.ResultsOf the 244 patients, 36 dropped out, 112 completed 6 months of treatment, and the other 96 completed 12 months of treatment. The mean number of nights by which patients reported sleep quality as “good” or “very good” was significantly higher during PRM than before treatment. There was no evidence of tolerance to PRM. Discontinuation of PRM was not associated with rebound insomnia or withdrawal symptoms; on the contrary, residual benefit was observed. PRM was well tolerated, and there was no suppression of endogenous melatonin production.ConclusionResults support the efficacy and safety of PRM in primary insomnia patients aged 20–80 throughout 6–12 months of continuous therapy. PRM discontinuation even after 12 months was not associated with adverse events, withdrawal symptoms, or suppression of endogenous melatonin production.

38 COST EFFECTIVENESS OF TRADITIONAL CHINESE ACUPUNCTURE AS ADJUNCTIVE THERAPY IN OSTEOARTHRITIS OF THE KNEE

Purpose: There are significant health care costs associated with osteoarthritis (OA) of the knee due to several factors including both utilization of health care services and loss of productivity. We previously reported that traditional Chinese acupuncture (TCA) given in a tapering schedule over 26 weeks was associated with significantly greater improvement in pain and function when compared to both sham acupuncture and education alone (Ann Intern Med 2004;141:901-10). Herein, we report results of a cost effectiveness analysis of TCA in comparison to education alone as adjunctive treatment for knee OA. Methods: This analysis was limited to the 190 and 189 patients randomized to the TCA and education alone groups, respectively; data on patients randomized to sham acupuncture were not used in this analysis. To estimate costs, we used self-reported data from the Health Assessment Questionnaire (HAQ) that was completed by participants at their 26 week close-out visit to determine health care utilization including medication use, hospitalizations, outpatient surgeries or procedures, emergency room visits and doctor or health care worker visits. In addition, we included the costs of providing the interventions. To measure effectiveness, we estimated quality adjusted life years (QALYs) gained, based on self-reported data from the EuroQoL (EQ-5D) completed at baseline, 8and 26 weeks. The changes in health utility used to estimate gains in QALYs were calculated using generalized estimating equations to account for the multiple observations per study subject. Missing data were assumed to be missing at random. We used 1000 bootstrapped repetitions to describe the distribution of the cost-effectiveness results. In a secondary analysis, we also estimated the costs per additional OMERACT/OARSI responder. Results: At 26 weeks, HAQ and EQ-5D data were available on 131 (92.3%) of 142 and 91 (84.3%) of 108 subjects who completed the entire study period in the TCA and education alone groups, respectively. Participants in the TCA group used fewer medications, had fewer hospitalizations (7.6% v 8.9%), outpatient surgeries (13.0% v 16.5%), emergency room visits (8.4% v 11.0%) and mean number of health care worker or doctor visits (7.1% v 7.9%), but slightly higher mean number of nights in hospital (0.61 v 0.58) than those in the education alone group. Over the 26-week study period, the TCA group gained 0.06 QALYs when compared to education alone group. The median cost-effectiveness was $32,000/QALY gained. The cost-effectiveness acceptability curve shows that 95% of 1000 repetitions were consistent with a cost-effectiveness result of less than $50,000/QALY gained (see Figure 1). As previously reported, 52% of the TCA group and 30% of the education alone group could be classified as OMERACT/OARSI responders. The cost per additional responder achieved in the TCA group was estimated as $30,000.

Evaluation of a Nurse-run asthma clinic in general practice.

Since 1985, nurse-run asthma clinics have been developing and are now widespread in the United Kingdom, having been greatly stimulated by the New Contract for General Practice (1990). To date, there have been few definitive studies evaluating such clinics. This study, in two adjacent general practices in semi-rural Somerset, evaluates the effect of nurse-run clinics on patients' symptoms, pulmonary function, and healthcare utilisation over a four-month period. One hundred and twenty-nine subjects, aged 2-79 years, were recruited from the two practices over a one-year period (1991-1992). All patients identified in either practice who had used preventive therapy in the preceding 12 months were eligible and were included if they had a positive exercise or reversibility (20%) test and had not previously received formal asthma education. A pre- and post-experimental study design was used. Subjects' symptoms, pulmonary function, and health care in the preceding eight weeks were assessed at intake and at 16 weeks; the nurse education being delivered at intake, one and four weeks. Both mean number of days off work/school and mean number of nights on which waking occurred fell (p < 0.001). Peak expiratory flow rates and forced expiratory volumes improved during the study period (p < 0.001 and p < 0.01 respectively). Use of antibiotics, oral steroids, and rescue bronchodilator use all improved significantly (p < 0.001). Physician attendances were also reduced. A nurse-run asthma clinic in general practice is an effective way to improve symptoms, pulmonary function, and health care utilisation for asthmatic patients.

PGD10 Bambuterol is A More Cost-Effective Treatment than Salmeterol in Asthma Patients with Nocturnal Symptoms

OBJECTIVE:To compare the cost-effectiveness of oral bambuterol (B) 20 mg once daily with that of salmeterol (S) pMDI 50 mg twice daily for treatment of asthma patients with nocturnal symptoms. METHODS:126 patients, aged 18–70 years and using inhaled corticosteroids at a constant daily dose and with an FEV1 40–85% of predicted normal value, were included in this double-blind, randomized, parallel-group study (2 weeks of run-in and 6 weeks of treatment) in the UK, Italy, and Norway. During run-in, they had to show a nocturnal awakening or early awakening due to asthma symptoms that required rescue medication at least once, and a 15% fall in overnight PEF on 3 out of the last 7 days. Morning and everning PEF were measured and tremor was scored. The effectiveness variables in the cost-effectiveness analysis were symptom-free days and number of nights with no awakenings. Costs for both study and rescue medication were calculated. RESULTS:There were no statistically significant differences between B and S regarding morning and evening PEF (change from baseline), tremor, and the effectiveness variables. Mean number of symptom-free days were 20–25%, and mean number of nights with no awakenings were 69–77%. Costs (study + rescue medication) were lower during bambuterol treatment in all three countries. UK Italy Norway Daily cost Bamb Salm Bamb Salm Bamb Salm US$ 0.71 1.35 0.67 0.92 0.74 1.19 CONCLUSION:Treatment with bambuterol is more cost-effective than treatment with salmeterol in asthma patients with nocturnal symptoms.