The efficacy of a transdiagnostic sleep intervention for outpatients with sleep problems and depression, bipolar disorder, or attention deficit disorder: study protocol for a randomized controlled trial.

BACKGROUND: Patients with mental disorders have a higher prevalence of sleep problems than the general population. Sleep problems may include insomnia, circadian rhythm disorders, or hypersomnia. A transdiagnostic approach combining cognitive behavioral therapy for insomnia (CBT-I) with chronotherapy addressing a broad range of sleep problems has shown promising results in a limited number of studies. The aim of the study is to investigate the efficacy of a transdiagnostic sleep intervention for patients with sleep problems comorbid to bipolar disorder, unipolar depression, or attention deficit disorders. The primary hypothesis is that the intervention improves sleep quality compared with a control group. The secondary hypotheses are that the intervention increases subjective and objective sleep efficiency, reduces sleep onset latency, wake after sleep onset, number of awakenings, and severity of insomnia; and that it improves well-being, personal recovery, work ability, and consumption of sleep medication compared with a control group. METHODS: The study is a randomized controlled trial enrolling 88 outpatients with bipolar disorder, major depression, or attention deficit disorder with symptoms of various sleep problems (insomnia, circadian rhythm disorders, or hypersomnia). Patients are allocated to either an intervention group receiving six sessions of transdiagnostic sleep treatment or to a control group receiving a single session of sleep hygiene education. Assessments are made at baseline, at week two, and after 6 weeks in both groups. Actigraphy is performed continuously throughout the 6-week study period for all patients. The primary outcome is changes in the subjective appraisal of sleep quality (Pittsburgh Sleep Quality Index). The secondary outcomes are changes in sleep efficiency, sleep onset latency, wake after sleep onset, number of nocturnal awakenings (based on actigraph and sleep diary data), changes in insomnia severity (Insomnia Severity Index), well-being (WHO-5 Well-Being Index), personal recovery (INSPIRE-O), work ability (Work Ability Index), and consumption of sleep medication (sleep-diaries). DISCUSSION: The study was initiated in 2022 and the inclusion period will continue until mid-2024. The results may have implications for the development and implementation of additional treatment options for patients with mental disorders and comorbid sleep problems. TRIAL REGISTRATION: ClinicalTrials.gov. NCT05406414. Registered on June 6, 2022.

Radiographic outcome after maxillary sinus floor augmentation with allogeneic adipose tissue-derived stem cells seeded on deproteinized bovine bone mineral. A randomized controlled experimental study.

The objective was to test the hypothesis of no difference in radiographic outcome after maxillary sinus floor augmentation (MSFA) with allogeneic adipose tissue-derived stem cells (ASCs) seeded on deproteinized bovine bone mineral (DBBM) (test) compared with excipient on DBBM (control). Eighteen minipigs were assigned into three groups of six animals and euthanised after one month (T1), two months (T2), and four months (T3), respectively. Each maxillary sinus was randomly allocated to either test or control with an equal volume of graft. Computed tomography scans (CTs) after MSFA (T0) were compared with CTs after euthanasia to evaluate graft volume (GV) changes and bone density (BD) using three-dimensional measurements and Hounsfield units. GV was larger in test compared with control at T1 (P = 0.046), whereas GV was larger in control compared with test at T3 (P = 0.01). BD increased from T0 to T1-T3 (P < 0.001) with both treatments. Higher BD was observed in control compared with test at T3 (P = 0.01), while no significant difference was observed at T1 and T2. Conclusively, the present study demonstrate that allogeneic ASCs seeded on DBBM in conjunction with MSFA seemed not to improve the radiographic outcome compared with excipient on DBBM. However, radiological outcomes need to be supplemented by bone histomorphometry before definitive conclusions can be provided about the beneficial use of allogeneic ASCs seeded on DBBM in conjunction with MSFA compared with DBBM alone.

Systematic review of interventions targeting sickness absence among pregnant women in healthcare settings and workplaces.

OBJECTIVES: The high rate of sickness absence from work during pregnancy is recognised as a problem, and may be higher than necessary from a health perspective. The aim was to evaluate the effectiveness of interventions in healthcare settings and workplaces targeting sickness absence among pregnant women. METHODS: Studies were eligible if they included pregnant women participating in any intervention in healthcare settings or workplaces. The outcome was length of sickness absence in days or number of episodes. Study design had to be either randomised controlled trials (RCTs) or quasi-experimental studies.The search for studies was conducted in PubMed, Scopus, CINAHL, PsycINFO, ClinicalTrials.gov and WHO trial registry. Risk of bias was assessed by the Joanna Briggs Institute standardised quality assessment instrument. RESULTS: A total of nine studies were quality assessed and of these, four were excluded due to insufficient methodological quality. Five RCTs conducted in healthcare settings in Sweden and Norway were included. Due to heterogeneity, meta-analysis was not performed.Two RCTs examined complementary and alternative medicine and three RCTs the effect of physical exercise. In general, the frequency of women on sickness absence was lower in the intervention groups than the control groups, however, only among pregnant women who participated in a 12-week exercise programme, the frequency was significantly lower (22% vs 30%, p=0.04). CONCLUSION: The evidence of interventions targeting sickness absence among pregnant women in healthcare settings is sparse, and no studies were conducted at workplaces.Future interventions including physical activity provided in collaboration with healthcare settings and workplaces are requested. Studies should measure sickness absence based on valid methods, measure compliance to the intervention and provide transparency of statistical methods. PROSPERO REGISTRATION NUMBER: CRD42018084802.

Feasibility of capsule endoscopy for direct imaging of drug delivery systems in the fasted upper-gastrointestinal tract.

PURPOSE: To develop a minimally-invasive method for direct visualization of drug delivery systems in the human stomach and to compare the obtained results with an established in vitro model. The method should provide the capsule rupture, dispersion characteristics, and knowledge regarding the surrounding physiological environment in the stomach. METHODS: A capsule endoscopic method was developed. The disintegration time, dispersion characteristics and the impact of the physiological environment on different lipid based delivery systems in different gelatin capsules in the fasted stomach of nine healthy volunteers were visualized. Biorelevant dissolution studies using a USP II apparatus and a droplet size analysis of the released SNEDDS were performed. RESULTS: Visualization of the behavior of both hard and soft gelatin capsules formulations was possible. The disintegration and dispersion of EP oil in a soft capsule and SNEDDS in a hard shell capsule were visualized. The in vitro release rates were different from the in vivo release rates of the soft capsule due to volume, fluid composition and motility differences but not for the hard capsule containing SNEDDS. CONCLUSIONS: A minimally-invasive capsule endoscopic method was developed for direct visualizing of drug delivery systems in the human stomach and maybe later, in the duodenum.