scholarly journals Effect of Hemodiafiltration on Self-Reported Sleep Duration: Results from a Randomized Controlled Trial

2019 ◽  
Vol 49 (1-2) ◽  
pp. 168-177
Author(s):  
Maggie Han ◽  
Murilo Guedes ◽  
John Larkin ◽  
Jochen G. Raimann ◽  
Ana Beatriz Lesqueves Barra ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Duration ◽  
Controlled Trial ◽  
High Volume ◽  
The Self ◽  
Poor Sleep ◽  
High Flux ◽  
Dialysis Patients ◽  
Randomized Controlled ◽  
The Impact

Introduction: Dialysis patients suffer from poor sleep duration and quality. We examined the self-reported sleep duration in patients randomized to either high-volume hemodiafiltration (HDF) or high flux hemodialysis (HD). Methods: Patients from 13 Brazilian dialysis clinics were enrolled in the HDFIT randomized controlled trial (RCT) investigating the impact of HDF on physical activity and self-reported outcomes. Self-reported sleep duration was taken from patient diaries recording sleep start and end time over a week during baseline, months 3 and 6, respectively. Sleep duration was analyzed by shift and nights relative to dialysis. Results: The HDFIT study enrolled 197 patients; sleep data were available in 173 patients (87 HD; 86 HDF). Patients’ age was 53 ± 15 years, 57% were white, 72% were male, 34% had diabetes, Kt/V was 1.54 ± 0.40, and albumin 3.97 ± 0.36 g/dL. Most patients reported sleeping 510–530 min/night. At 3 months, HDF patients slept 513 ± 71 min/night, HD patients 518 ± 76 min/night. At 6 months, HDF patients slept 532 ± 74 min/night, HD patients 519 ± 80 min/night. At baseline, 1st shift patients slept 406 ± 86 min the night before HD, 534 ± 64 min the night after HD, and 496 ± 99 min the night between 2 non-HD days. Compared to patients in the 2nd and 3rd shifts, patients dialyzed in the 1st shift slept less in the night before dialysis. Similar patterns were seen after 3 and 6 months. Conclusion: In our RCT, the dialysis modality (HDF vs. HD) had no effect on self-reported sleep duration. In both groups, dialysis in the 1st shift adversely affected self reported sleep duration.

scholarly journals P1070ONLINE HIGH-VOLUME HEMODIAFILTRATION REDUCES PRE-DIALYSIS LEVELS OF INDOXYL SULFATE COMPARED TO HIGH-FLUX HEMODIALYSIS: RESULTS FROM HDFIT MULTICENTRIC RANDOMIZED CONTROLLED TRIAL

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Jordana Lima ◽  
Murilo Guedes ◽  
Silvia Rodrigues ◽  
Ana Clara Flórido ◽  
Ana Beatriz Barra ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Plasma Levels ◽  
Controlled Trial ◽  
High Volume ◽  
Indoxyl Sulfate ◽  
High Flux ◽  
Randomized Controlled ◽  
Mean Differences ◽  
Over Time

Abstract Background and Aims Online High-Volume Hemodiafiltration (OL-HDF) combines convective and diffusive clearances and is associated with better outcomes compared to standard hemodialysis (HD). Although HDF has been shown to improve the clearance and pre-dialysis concentration of middle size uremic toxins, little is known about its effect on concentration of protein-bound uremic toxins (PBUT), particularly in comparison to high-flux HD. Here, we investigated whether high-volume post-dilution OL-HDF impacts pre-dialysis plasma levels of PBUT indoxyl sulfate (IxS), p-cresyl sulfate (pCS) and indole 3-acetic acid (IAA) compared to high-flux HD over time, since accumulation of these PBUT has been associated with increased overall mortality of CKD patients. Method This is post hoc analysis of the multicentric randomized controlled trial (RCT) studying the impact of post-dilution high-volume OL-HDF versus high-flux HD on measured physical activity (HDFit - clinicalTrials.gov: NCT02787161), which included clinically stable HD patients with a vintage >3 to <24 months. Total plasma levels of IxS, pCS and IAA were determined by high performance liquid chromatography (HPLC) with fluorescence detection at baseline, 3 and 6 months. The difference between HDF and HD in respect to changes in the PBUT concentrations during the follow up, analyzed using linear mixed effect models, was compared. Results are presented as mean differences between groups in the change from baseline along with 95% confidence intervals (CI). Results 193 patients (mean age 53 years old, 70% males and 60% white – no differences between groups) were analyzed. There were no differences between HD and OL-HDF groups regarding clinical and biochemical characteristics at the baseline. In the OL-HDF group, 99% of patients achieved a convective volume higher than 22 L and both groups had similar dialysis session duration and blood flows throughout the follow up. The mean differences (95% CI) in concentrations over time for PBUTs among HDF and HD groups are shown in Figure 1. HDF group presented a significantly lower trajectory of IxS levels and a lower trajectory of pCS levels than HD group. Trajectories of IAA levels were not different between groups. Conclusion OL-HDF reduced the pre-dialysis concentration of IxS and pCS through 6 months-period compared to high-flux HD.

scholarly journals The Impact of a Randomized Controlled Trial of a Lifestyle Intervention on Sleep Among Latina Postpartum Women

2021 ◽  
Author(s):  
Marquis Hawkins ◽  
Bess Marcus ◽  
Penelope Pekow ◽  
Milagros C Rosal ◽  
Katherine L Tucker ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Sleep Quality ◽  
Sleep Duration ◽  
Controlled Trial ◽  
Postpartum Women ◽  
Health And Wellness ◽  
Latina Women ◽  
Onset Latency ◽  
Randomized Controlled ◽  
The Impact

Abstract Background Poor sleep is associated with adverse outcomes among postpartum women. Exercise may improve sleep, but this has not been well examined in the postpartum period. Purpose To examine the impact of a culturally modified, individually tailored lifestyle intervention on sleep outcomes among postpartum Latina women. Methods Estudio PARTO was a randomized controlled trial aimed at reducing Type 2 diabetes among Latina women with abnormal glucose tolerance in pregnancy. Participants were randomized to a lifestyle (i.e., diet and exercise; n = 70) or a health and wellness control intervention (n = 78) in late pregnancy (baseline). The Pittsburgh Sleep Quality Index (PSQI) was used to measure sleep quality (PSQI score), onset latency (minutes per night), duration (hours per night), efficiency (percentage of the time in bed asleep), and daytime dysfunction at baseline, 6 weeks, 6 months, and 12 months postpartum. Results Mean PSQI score (6.56 ± 3.87), sleep duration (6.84 ± 1.75 hr/night), and sleep efficiency (79.70% ± 18.10%) did not differ between the arms at baseline. Mixed-effects models indicated a greater decrease of 1.29 in PSQI score (i.e., improved sleep quality) in the lifestyle versus health and wellness arm (95% confidence interval [CI] = −2.50 to −0.08, p = .04) over follow-up. There was the suggestion of a smaller decrease in sleep duration (mean = 0.48 hr/night, 95% CI = −0.10 to 1.06, p = .10) in the lifestyle versus health and wellness arm. There were no statistically significant differences in other sleep outcomes between arms. Conclusions Findings suggest that lifestyle interventions improve sleep quality but not sleep duration, sleep onset latency, sleep efficiency, or daytime dysfunction in postpartum Latina women and, therefore, may hold promise for improving subsequent mental and physical health in this population. Clinical Trials Registration NCT01679210.

scholarly journals A 21-Day School-Based Toothbrushing Intervention in Children Aged 6 to 9 Years in Indonesia and Nigeria: Protocol for a Two-Arm Superiority Randomized Controlled Trial

10.2196/14156 ◽  
2020 ◽  
Vol 9 (2) ◽  
pp. e14156
Author(s):  
Paulo Melo ◽  
Sinead Malone ◽  
Arathi Rao ◽  
Charlotte Fine
Keyword(s):  
Randomized Controlled Trial ◽  
Oral Health ◽  
Controlled Trial ◽  
Day School ◽  
The Self ◽  
Phase Iii ◽  
School Program ◽  
Fluoride Toothpaste ◽  
Randomized Controlled ◽  
The Impact

Background The World Health Organization reports that dental cavities affect 60% to 90% of children globally. FDI World Dental Federation and Unilever Oral Care have developed public health programs to improve brushing habits over their 12-year partnership. The last of these (phase III) named Brush Day & Night aimed to educate children on brushing twice daily with a fluoride toothpaste and gave useful information for a new project, phase IV. The 21-day Brush Day & Night program is an intense education activity designed to establish the habit of brushing day and night with a fluoride toothpaste. The program involves daily brushing instruction and includes free toothpaste and toothbrushes. Objective The main objective of the study is to evaluate the impact of a 21-day school program on children’s oral health. As a secondary objective, we aim to evaluate the impact on the knowledge, behavior, toothbrushing habits, and quality of life in school children aged 6 to 9 years after a 21-day school program and compare with baseline and a control group as measured by the self-reported questionnaires issued to children (in particular, the self-reported brushing frequency and positive responses on fluoridated toothpaste use). The enduring nature of the program will be determined by the inclusion of 8- and 24-week time points. Methods The study is a 2-arm superiority randomized controlled trial. Clusters in this study are infant and junior schools in Indonesia and Nigeria. The study aims to recruit 20 schools with children aged 6 to 9 years in each country. At baseline, children in both intervention and control schools will answer a questionnaire and have their clinical oral health assessed using the Simplified Oral Hygiene Index (OHI) and Decayed Missing and Filled Teeth index. Children in the intervention schools will then take part in a structured 21-day Brush Day & Night intervention. Children in the control schools will be provided with free toothpaste and toothbrushes but will not receive the 21-day intervention. The questionnaires and OHI assessments are repeated after the 21-day program is completed and again 8 weeks later and 24 weeks later for all participating children. Parents/carers/guardians of all children will sign the informed consent and complete questionnaires on their own experience and attitudes toward oral health and toothbrushing routine at each of the four times points (baseline, 21 days, 8 weeks, and 24 weeks). The study will be conducted by the national dental associations of Indonesia and Nigeria and was approved by the ethics committees of both countries. Results The study is ongoing. Recruitment of schools started in Indonesia in February 2018 and in Nigeria in April 2018 for the first part of the study, which concluded in Indonesia in September 2018 and in Nigeria in November 2018. The second part of the study (the second half of the schools) started in November 2018 in Indonesia and December 2018 in Nigeria. Conclusions We expect to collect all the data during 2019 and publish findings from the study by March 2020. Trial Registration ClinicalTrials.gov NCT04001296; https://tinyurl.com/selxraa International Registered Report Identifier (IRRID) DERR1-10.2196/14156

Investigating the Impact of Cognitive Training for Individuals With Bothersome Tinnitus: A Randomized Controlled Trial

2021 ◽  
pp. 019459982199474
Author(s):  
Maggie Xing ◽  
Dorina Kallogjeri ◽  
Jay F. Piccirillo
Keyword(s):  
Randomized Controlled Trial ◽  
Cognitive Training ◽  
Mixed Model ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Functional Index ◽  
Open Label ◽  
Randomized Controlled ◽  
The Impact

Objective To evaluate the effectiveness of cognitive training in improving tinnitus bother and to identify predictors of patient response. Study Design Prospective open-label randomized controlled trial. Setting Online. Methods Participants were adults with subjective idiopathic nonpulsatile tinnitus causing significant tinnitus-related distress. The intervention group trained by using auditory-intensive exercises for 20 minutes per day, 5 days per week, for 8 weeks. The active control group trained on the same schedule with non–auditory intensive games. Surveys were completed at baseline, 8 weeks, and 12 weeks. Results A total of 64 participants completed the study. The median age was 63 years (range, 25-69) in the intervention group and 61 years (34-68) in the control group. Mixed model analysis revealed that within-subject change in Tinnitus Functional Index in the intervention group was not different than the control group, with marginal mean differences (95% CI): 0.24 (–11.20 to 10.7) and 2.17 (–8.50 to 12.83) at 8 weeks and 2.33 (–8.6 to 13.3) and 3.36 (–7.91 to 14.6) at 12 weeks, respectively. When the 2 study groups were compared, the control group had higher Tinnitus Functional Index scores than the intervention group by 10.5 points at baseline (95% CI, –0.92 to 29.89), 8.1 at 8 weeks (95% CI, –3.27 to 19.42), and 9.4 at 12 weeks (95% CI, –2.45 to 21.34). Conclusion Auditory-intensive cognitive training was not associated with changes in self-reported tinnitus bother. Given the potential for neuroplasticity to affect tinnitus, we believe that future studies on cognitive training for tinnitus remain relevant.

scholarly journals An internet-based self-help intervention for people with psychological distress due to COVID-19: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Noemi Anja Brog ◽  
Julia Katharina Hegy ◽  
Thomas Berger ◽  
Hansjörg Znoj
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
The Self ◽  
Randomized Controlled ◽  
Self Help ◽  
Parallel Group ◽  
Related Quality ◽  
Health Related

Abstract Background The coronavirus-19 (COVID-19) has reached pandemic status and is affecting countries all over the world. The COVID-19 pandemic is accompanied by various stressors that require adjustment in everyday life and possibly changes in personal future prospects. While some individuals cope well with these challenges, some develop psychological distress including depressive symptoms, anxiety, or stress. Internet-based self-help interventions have proven to be effective in the treatment of various mental disorders such as depression and anxiety. Based on that, we developed an internet-based self-help program for individuals with psychological distress due to the situation surrounding the COVID-19 pandemic. The 3-week self-help program consists of 6 modules comprising texts, videos, figures, and exercises. Participants can request guidance within the self-help program (guidance on demand). The primary aim of this study is to evaluate the efficacy and feasibility of the self-help program compared to a waiting control condition. Methods The design is a parallel group randomized controlled trial. Participants are allocated to a 3-week self-help intervention plus care as usual or a 3-week waiting period with only care as usual. There are follow-ups after 6 weeks and 18 weeks. At least 80 participants with COVID-19 pandemic related psychological distress will be recruited. Primary outcome are depressive symptoms. Secondary outcomes include anxiety and chronic stress, suicidal experiences and behavior, health-related quality of life, generalized optimism and pessimism, embitterment, optimistic self-beliefs, emotion regulation skills, loneliness, resilience, and the satisfaction with and usability of the self-help program. Discussion To the best of our knowledge, this is one of the first studies investigating the efficacy of an internet-based self-help program for psychological distress due to the situation surrounding the COVID-19 pandemic. Thus, the results of this study may give further insight into the use of internet-based self-help programs in pandemic-related psychological distress. Trial registration ClinicalTrials.gov NCT04380909. Retrospectively registered on 8 May 2020.

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