scholarly journals Sleep health education and a personalized smartphone application improve sleep and productivity and reduce healthcare utilization among employees: Results of a randomized clinical trial

2021 ◽  
Author(s):  
Rebecca Robbins ◽  
Matthew D Weaver ◽  
Stuart Quan ◽  
Jason P Sullivan ◽  
Salim Qadri ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Sleep Disorders ◽  
Randomized Clinical Trial ◽  
Sleep Duration ◽  
Healthcare Utilization ◽  
Workplace Health Promotion ◽  
Sleep Health ◽  
Waitlist Control ◽  
Study Results ◽  
Workplace Outcomes

Sleep deficiency and undiagnosed or untreated sleep disorders are pervasive among employed adults, yet often ignored in the context of workplace health promotion programs among employers. Smartphone applications (app) are a promising, scalable approach to improving sleep among employees. In this randomized clinical trial, we evaluate the dayzz app, a personalized sleep training program that promotes healthy sleep and sleep disorders awareness through personalized, comprehensive sleep improvement solutions. In a sample of daytime employees affiliated with a large healthcare organization, we evaluated the dayzz app in a parallel-group, randomized, waitlist control trial. Participants were randomly assigned to either use the dayzz app throughout the study or the waitlist control condition where they would receive the dayzz app at the end of the study period. We collected data on employee sleep (e.g., sleep duration, sleep health behavioral changes); workplace outcomes (e.g., employee presenteeism, absenteeism, and performance); and healthcare utilization (e.g., mental health, ambulatory visits, and emergency room visits), throughout the study. Results show that those assigned to the experimental condition exhibited an increase in healthy sleep behaviors; an increase in sleep duration; a trend toward a more regular sleep schedule; and a significant increase in overall sleep quality. Regarding workplace outcomes, results showed that those in the experimental condition also demonstrated a trend toward less absenteeism and significantly lower presenteeism; and those in the experimental condition reported lower healthcare utilization. Results from this randomized clinical trial demonstrate that a workplace sleep wellness program can be beneficial to both the employee and employer.

Sleep health and diabetes: The role of sleep duration, subjective sleep, sleep disorders, and circadian rhythms on diabetes

2019 ◽  
pp. 213-225
Author(s):  
Azizi A. Seixas ◽  
Rebecca Robbins ◽  
Alicia Chung ◽  
Collin Popp ◽  
Tiffany Donley ◽  
...  
Keyword(s):  
Circadian Rhythms ◽  
Sleep Disorders ◽  
Sleep Duration ◽  
Sleep Health ◽  
Subjective Sleep

scholarly journals A Collaborative Paradigm for Improving Management of Sleep Disorders in Primary Care: A Randomized Clinical Trial

SLEEP ◽  
2016 ◽  
Vol 39 (1) ◽  
pp. 237-247 ◽  
Author(s):  
Jack D. Edinger ◽  
Janet Grubber ◽  
Christi Ulmer ◽  
Jennifer Zervakis ◽  
Maren Olsen
Keyword(s):  
Primary Care ◽  
Clinical Trial ◽  
Sleep Disorders ◽  
Randomized Clinical Trial

scholarly journals Effects of Flaxseed Oil Consumption on Anthropometric Parameters in the Patients with Metabolic Syndrome: A Randomized Clinical Trial

2017 ◽  
Vol 6 (1) ◽  
pp. 44-51
Author(s):  
Atefeh Akrami ◽  
Farzad Nikaein ◽  
Siavash Babajafari ◽  
Shiva Faghih ◽  
Mohammad Javad Zibaeenejad
Keyword(s):  
Metabolic Syndrome ◽  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Sunflower Oil ◽  
Flaxseed Oil ◽  
Control Group ◽  
Alpha Linolenic Acid ◽  
Anthropometric Parameters ◽  
Anthropometric Measures ◽  
Study Results

Background: Flaxseed oil, as the main source of Alpha linolenic acid (ALA), decreases the production of Arachidonic acid (AA) from linoleic acid (LA) that plays an important role in the development of metabolic syndrome (MS). The aim of the present study was to compare the effects of flaxseed oil and sunflower oil on anthropometric parameters in patients suffering from MS. Materials and Methods: In this randomized clinical trial, 60 participants aged 30-60 years who suffered from MS were selected according to ATP III definition and were divided into two even groups receiving flaxseed oil and sunflower oil. Each group received 25 ml of the specified oil on a daily basis for 7 weeks. The anthropometric measures were evaluated on the first and last days of the study. Results: No significant differences were observed between the two groups regarding weight. However, waist circumference reduced significantly in the flaxseed oil group compared to the control group (P=0.001). Conclusions: The ALA might prevent the increase in adipose tissues. Therefore, it seems that flaxseed oil has beneficial effects on MS. [GMJ.2017;6(1):44-51]

scholarly journals Lithium and preventing chemotherapy-induced peripheral neuropathy in breast cancer patients: a placebo-controlled randomized clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
S. Najafi ◽  
Z. Heidarali ◽  
M. Rajabi ◽  
Z. Omidi ◽  
F. Zayeri ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trial ◽  
Peripheral Neuropathy ◽  
Randomized Clinical Trial ◽  
Cancer Patients ◽  
Common Adverse Effect ◽  
Signs And Symptoms ◽  
Breast Cancer Patients ◽  
Double Blind ◽  
Study Results

Abstract Background Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of some chemotherapy regimens. Lithium has been suggested for CIPN in some animal studies. We aimed to study lithium’s preventive effect on CIPN in breast cancer patients treated with taxanes and platinum-based medications. Method A double-blind placebo-controlled randomized clinical trial (RCT) was implemented on 36 breast cancer patients in two equal-size groups by block randomization. Participants in both groups consumed daily tablets, either placebo or lithium (300 mg), for 5 days in each course of chemotherapy. The tablets were prescribed 1 day before the start of chemotherapy. The electromyography (EMG) and nerve-conduction-velocity (NCV) tests were achieved before the first chemotherapy, 3 and 9 months after the treatment. The changes and signs or symptoms of CIPN, such as numbness, tingling, freezing, sensitivity to touch, muscle weakness, fibrillation, and knee and elbow reflex disorders, were recorded by examination. The trend of outcome changes was compared between two groups during the 9 months of study. Results In both groups, neurologic signs and symptoms were exacerbated during the first 3 months and improved up to the ninth month of study. Results showed significant changes of all EMG-NCV variables during the 9 months of research in each group (P < 0.001), but the interaction of time and group effect was not significant in none of those indices. All symptoms changed significantly over the study time (P < 0.001) without significant statistical difference between the two groups (P=0.352). No side effect was found during the study. Conclusion The study showed that 300 mg lithium prescription once daily for 5 days might not effectively prevent CIPN in breast cancer patients. Evaluation of lithium effect on CIPN on different cancers in future studies is suggested. Trial registration Iranian Registry of Clinical Trials IRCT20160813029327N10.  Registration date: May 16, 2018.

scholarly journals Public access to protocols of contemporary cancer randomized clinical trials

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Christopher Babu ◽  
Loren Mell ◽  
Nancy Lee ◽  
Kaveh Zakeri
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Randomized Clinical Trials ◽  
Public Access ◽  
Research Protocol ◽  
Study Results ◽  
Research Transparency

AbstractAccess to randomized clinical trial (RCT) protocols is necessary for the interpretation and reproducibility of the study results, but protocol availability has been lacking. We determined the prevalence of protocol availability for all published cancer RCTs in January 2020. We found that only 36.1% (48/133) of RCTs had an accessible protocol and only 11.3% of RCTs (15/133) had a publicly accessible protocol that was not behind a paywall. Only 18.0% (24/133) of RCTs were published in conjunction with the protocol on the journal website. In conclusion, few cancer RCTs have an accessible research protocol. Journals should require publication of RCT protocols along with manuscripts to improve research transparency.

Initial Results of a Randomized, Prospective Trial of Prophylaxis To Prevent Joint Disease in Young Children with Factor VIII (FVIII) Deficiency.

Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 3-3 ◽  
Author(s):  
Marilyn J. Manco-Johnson ◽  
Thomas C. Abshire ◽  
Deborah Brown ◽  
George R. Buchanan ◽  
Alan R. Cohen ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Young Children ◽  
Randomized Clinical Trial ◽  
Cartilage Damage ◽  
Intensive Therapy ◽  
Prospective Trial ◽  
Joint Damage ◽  
Physical Exam ◽  
Joint Function ◽  
Study Results

Abstract Background: Retrospective reviews of hemophilia therapy correlate normal joint X-ray (XR) and physical exam (PE) with early institution of routine infusions of FVIII dosed to prevent bleeding. Although the National Hemophilia Foundation recommended prophylaxis for all persons with severe hemophilia in 1995, fewer than half of affected persons in the US have adopted prophylaxis due to cost, effort, lack of perceived need and complications. Objective: The “Joint Outcome Study” was constructed as a multi-center, open-label, two-arm, prospective, randomized clinical trial to compare full prophylaxis with an intensive treatment regimen for joint hemorrhage. Methods: A regimen of every other day infusions of FVIII at 25 U/kg to prevent hemorrhage (prophylaxis, P) was compared with intensive therapy using ≥ 3 infusions totaling ≥ 80 U/kg FVIII at the time of each joint hemorrhage to minimize joint damage (enhanced episodic, EE). Primary outcome was the proportion of boys in each arm with bone or cartilage damage on XR or magnetic resonance imaging (MR) of index joints (elbows, knees, and ankles). Outcomes were judged independently by two research radiologists who were blinded to treatment arm and bleed history, with a third for discrepant readings. Other outcomes included joint function on a physical exam scale validated for young children (PE), # of joint hemorrhages and factor utilization. Boys were followed from entry between 12 and 30 months until age 6 years. At entry all children had normal joints on XR and MR and had no more than two hemorrhages into any one joint. Results: Sixty-five boys were randomized to P (32) or EE (33). The study has been completed. While adjudication of XR and MR outcomes is still ongoing, clinical study results show the following: Children on P consumed more FVIII (mean 163 vs 47 infusions/year, P &lt; 0.001) and had fewer joint hemorrhages per year (0.47 vs 4.9, p &lt; 0.001) than boys on EE. PE scores for the six index joints were lower on the P arm compared with EE (mean score 4.7 vs. 8.6, p&lt; 0.01). Conclusion: This first randomized clinical trial of prophylaxis in young children with FVIII deficiency showed improved joint function by age 6 years in children on early every other day prophylaxis in comparison to an aggressive program of multiple infusions administered promptly at the time of joint hemorrhage. Joint structural outcome confirmation will be based on MR and XR.

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