Reporting results in U.S. clinical trials for obstructive sleep apnea and insomnia: How transparent are they?

BACKGROUND: Clinical trial transparency is important for scientific research and for the good of the general public. Diversity of study samples by race/ethnicity, gender, and age is important to ensure that results are generalizable. Moreover, reporting results might also be necessary to engage racial/ethnic minorities in clinical research. The primary objective of this study was to describe the results of clinical studies conducted for obstructive sleep apnea (OSA) and insomnia, two of the most prevalent sleep disorders. The secondary objective was to identify which factors were associated with voluntarily reporting the results. METHODS: We reviewed ClinicalTrials.gov, the public database of biomedical and behavioral research operated by the United States (U.S.) National Library of Medicine at the National Institutes of Health to ascertain the reports of demographic variables, including race/ethnicity of the studies conducted for OSA and insomnia. Since reporting race/ethnicity was an optional data feature, we searched for publications in PubMed using the unique national clinical trial identification number (NCTID). The national clinical trial identification number is assigned as soon as the trial is registered. The article extraction was conducted by graduate students and supervised by N.J.W. RESULTS: We identified 427 studies on OSA and 404 studies on insomnia. Results were reported for 122 studies. Based on the 122 studies with results that included studies that were terminated (n = 16) and/or completed (n = 105), and one study was listed as "active" but not recruiting. 46.7% studies involved drugs, 30.3% studied a medical device, and 8.2% investigated behavioral interventions. The age range of subjects was 2-99 years of age and 16.4% included an age range of 35-50 years. Twenty-nine studies (23.8%) reported race/ethnicity in ClinicalTrials.gov. Of these, 74% of subjects were white (n = 2,953); 20% black (n = 822); 1% Asian American (n = 40); 2% Hispanic/Latino (n = 77); and 3% of study subjects identified race/ethnicity as "other" (n = 118). With the PubMed search, we found an additional 24 studies that reported race/ethnicity. There was no difference in reports of race/ethnicity between studies for insomnia and studies for OSA. The intervention type labeled as "behavioral" was a significant predictor (odds ratio: 12.49, P-value ≤ .05, confidence interval: 1.002-155.62) for reporting results. CONCLUSION: The National Institutes of Health has mandated federally funded research include women and minorities and that they are representative of the U.S. POPULATION: Though gender was reported, few investigators and study sponsors reported the results of race/ethnicity, which begs the question about trial transparency for the future of sleep research. Presumably, the lack of reporting is related to low enrollment of ethnic/minorities included in these studies. Nonetheless, our key finding warrants increased attention to minority participation in sleep clinical studies and trial transparency.

Treatment of obstructive sleep apnea with CPAP improves chronic inflammation measured by neutrophil-to-lymphocyte ratio.

STUDY OBJECTIVES: Obstructive sleep apnea (OSA) is associated with chronic inflammation likely triggered by nocturnal, intermittent hypoxemia and increased adrenergic tone. The neutrophil-to-lymphocyte ratio (NLR) was recently described as a measure of subclinical systemic inflammation. Studies on the effect of continuous positive airway pressure (CPAP) therapy in OSA on subclinical inflammation measured by NLR are lacking. We hypothesize that NLR levels would improve as chronic inflammation diminishes in patients with OSA treated with CPAP. METHODS: We retrospectively reviewed patients in whom OSA was diagnosed and who were treated with CPAP therapy. Complete blood count (CBC) were obtained pretreatment and posttreatment for calculation of NLR, which was calculated by dividing the number of neutrophils by the number of lymphocytes. Patients with conditions known to affect NLR such as chronic infections, inflammatory diseases, active cardiovascular disease, and malignancies were excluded from the study. CPAP adherence downloads were obtained for all patients. RESULTS: Out of 184 patients in whom OSA was diagnosed and who were treated with CPAP, 109 met our study criteria, including baseline polysomnogram, baseline and posttreatment CBC, and available adherence download. We compared the NLR before and after treatment with CPAP. There was a significant difference in NLR before and after treatment with CPAP (P < .0001). There was also a significant difference in apnea-hypopnea index before and after treatment (P < .0001). We also assessed the relationship between CPAP adherence (percentage of days used for > 4 hours) and the change in NLR. NLR decreased significantly in both the adherent (CPAP use ≥ 70% of days; P = .014) and nonadherent groups (CPAP use < 70% of days; P = .0003). Finally, we noticed a significant direct correlation between CPAP adherence beyond 70% and the change in NLR (ΔNLR) (P = .046) in patients who had ≥ 70% adherence with CPAP, which was not observed in patients with < 70% adherence. CONCLUSIONS: The NLR may be a useful marker for monitoring improvement, as CPAP had a desirable effect on the chronic inflammation induced by OSA when measured by NLR in this study. Our results specifically suggest that the NLR values decrease significantly in patients using CPAP regardless of adherence, but with a more direct relationship in those who use it beyond 70% of days, at least 4 hours a day.

Transient Ischemic Attack and Cognitive Impairment: A Review.

Transient ischemic attack (TIA) is a neurologic deficit resulting from focal ischemia in the brain, spinal cord, or retina. Historically, the definition included symptom resolution within 24 hours. However, recent studies investigating cognition after TIA suggest that deficits in executive function persist at 7 days post-TIA, although few studies have examined these effects long term. Recent advances in neuroimaging techniques provide emerging evidence of permanent microvascular tissue damage in the brain, suggesting that the effects of TIA may persist beyond resolution of focal symptoms. A further challenge is that there is debate concerning the clinical definition of TIA and the use of diagnostic neuroimaging studies and standardization of neuropsychological tests used to evaluate cognitive deficits in this population. Subtle changes in memory, attention, and problem-solving abilities may negatively influence an individual's ability to adopt positive health behaviors. Despite advances in the field, more research is needed; hence, the purpose of this article is to provide an overview of clinical factors for clinicians and researchers to consider when investigating cognitive deficits among post-TIA populations. Definitions of TIA are reviewed, and the importance of neuropsychological evaluation and neuroimaging correlates of TIA in establishing a positive diagnosis will be discussed. Nurses especially in advanced practice roles are uniquely positioned to assess and implement treatments in at-risk groups and therefore should be knowledgeable about these possible cognitive effects.

Case study: the challenges of self-management of exacerbation of pulmonary symptoms.

PURPOSE: This case study demonstrates the signs and symptoms of pulmonary exacerbation and the challenges of self-management for a female veteran. DATA SOURCES: Data were obtained through the author's clinical practice in primary care nursing and research literature sources. DATA SYNTHESIS: The appropriate nursing diagnosis, nursing interventions, and patient outcomes were identified through the use of NANDA-International, the Nursing Interventions Classification, and the Nursing Outcomes Classification. CONCLUSIONS: This case study illustrates the appropriate nursing diagnosis, interventions, and outcomes pertinent to an individual with pulmonary exacerbations. It provides a framework for nurses in primary care when caring for individuals with pulmonary exacerbations. IMPLICATIONS FOR NURSING PRACTICE: Employing the NANDA-International standardized nursing diagnoses, the Nursing Interventions Classification and the Nursing Outcomes Classification provided the needed constructs for improving care for a patient that had pulmonary issues in a primary care setting.