FDA-cleared home sleep apnea testing devices.

The demand for home sleep apnea testing (HSAT) devices is escalating, particularly in the context of the coronavirus 2019 (COVID-19) pandemic. The absence of standardized development and verification procedures poses a significant challenge. This study meticulously analyzed the approval process characteristics of HSAT devices by the U.S. Food and Drug Administration (FDA) from September 1, 2003, to September 1, 2023, with a primary focus on ensuring safety and clinical effectiveness. We examined 58 reports out of 1046 that underwent FDA clearance via the 510(k) and de novo pathways. A substantial surge in certifications after the 2022 pandemic was observed. Type-3 devices dominated, signifying a growing trend for both home and clinical use. Key measurement items included respiration and sleep analysis, with the apnea-hypopnea index (AHI) and sleep stage emerging as pivotal indicators. The majority of FDA-cleared HSAT devices adhered to electrical safety and biocompatibility standards. Critical considerations encompass performance and function testing, usability, and cybersecurity. This study emphasized the nearly indispensable role of clinical trials in ensuring the clinical effectiveness of HSAT devices. Future studies should propose guidances that specify stringent requirements, robust clinical trial designs, and comprehensive performance criteria to guarantee the minimum safety and clinical effectiveness of HSATs.

The Mediating Role of Social Participation in Motoric Cognitive Risk and its Relation to Depression and Loneliness in Older Adults.

BACKGROUND: Motoric cognitive risk syndrome (MCR) reduces the quality of life, independence, and social interaction in older adults. Social participation is a potentially modifiable factor that benefits cognitive and mental health. This study explored the mediating roles of social participation between MCR and depression and between MCR and loneliness. METHODS: We performed a secondary analysis of data from the 2015-2016 National Social Life, Health, and Aging Project. Slow gait speed and cognitive decline were used to assess MCR. Mediation analysis was applied to two models, both of which used MCR as an exposure and social participation as a mediator. The outcomes were depression and loneliness for each model, respectively. RESULTS: Among 1,697 older adults, 196 (11.6%) had MCR. The mediating role of social participation was statistically significant in both models. The indirect effect (ß=0.267, p=0.001) of MCR on depression through social participation comprised 11.97% of the total effect (ß=2.231, p<0.001). The indirect effect (ß=0.098, p=0.001) of MCR on loneliness through social participation was 19.48% of the total effect (ß=0.503, p<0.001). CONCLUSION: Interventions to increase social participation may reduce depression and loneliness of older adults with MCR.

Longitudinal Changes in Dual Decline in Memory and Gait Speed Association with Instrumental Activities of Daily Living: Findings from the National Social Life, Health, and Aging Project.

Objective: We investigated the association between dual decline (DD) (loss of memory and gait speed) and the instrumental activities of daily living (IADL) degeneration in older adults. Methods: Data were drawn from the National Social Life, Health, and Aging Project (NSHAP) reflecting changes over 5 years. This study used the NSHAP data set wave 2 (2010-2011, N = 3196) and wave 3 (2015-2016, N = 4377). Results: Data from 1640 participants were retrieved. There were 601 people with DD and 1039 people without-DD. The DD group had a 28.4% (95% CI = 1.013-1.626) greater risk of degrading in IADL than the without-DD group (odds ratio = 1.284, p < .05). Conclusion: Current research can be used when establishing intervention programs or policies that can prevent IADL degradation through simple memory training and walking activities for older adults living in the community.

Morphological adjustment of senescent cells by modulating caveolin-1 status.

Morphological change is one of the cardinal features of the senescent phenotype; for example, senescent human diploid cells have a flat large shape. However, the mechanisms underlying such senescence-related morphological alterations have not been well studied. To investigate this situation, we characterized the senescence-dependent changes of cellular structural determinants in terms of their levels and activities. These determinants included integrins, focal adhesion complexes, and small Rho GTPases, and special emphasis was placed on their relationships with caveolin-1 status. We observed that the expression integrin beta(1) and focal adhesion kinase (FAK) were increased and that the phosphorylations of FAK and paxillin, hallmarks of focal adhesion formation, were also increased in senescent human diploid fibroblast cells. Moreover, the Rho GTPases Rac1 and Cdc42 were found to be highly activated in senescent cells. In addition, focal adhesion complexes and Rho GTPases were up-regulated in the caveolin-rich membrane domain in the senescent cells. Activated Rac1 and Cdc42 directly interacted with caveolin-1 in senescent cells. Interestingly, caveolin-1 knock-out senescent cells, achieved by using small interfering RNA and antisense oligonucleotide, showed disrupted focal adhesion formation and actin stress fibers via the inactivation of FAK, which resulted in morphological adjustment to the young cell-like small spindle shape. Based on the results obtained, we propose that caveolin-1 plays an important role in senescence-associated morphological changes by regulating focal adhesion kinase activity and actin stress fiber formation in the senescent cells.