Methods: This double-blind, randomized, placebo-controlled trial involved fifty subjects with sleep complaints. Subjects with a Pittsburgh Sleep Quality Index (PSQI) score between 6 and 15 were randomized to receive either IQP-AO-101 or placebo for 6 weeks, following a run-in period of one week. Sleep parameters were assessed at baseline and after 1, 4, and 6 weeks using the modified Athens Insomnia Scale (mAIS). Subjects were also instructed to wear an activity tracker and keep a sleep diary during the study. Other questionnaires administered were the Frankfurt Attention Inventory (FAIR-2) and the Profile of Mood States (POMS-65). Blood samples for safety laboratory parameters were taken before and at the end of the study.
Results: After 6 weeks, subjects who consumed IQP-AO-101 reported significant improvements in mAIS scores compared with placebo, including mAIS total score (11.76 ± 6.85 vs 4.00 ± 4.80; p < 0.001); night parameters composite score (5.20 ± 3.80 vs 2.04 ± 3.16; p = 0.001); and day parameters composite score (6.56 ± 4.10 vs 1.96 ± 2.65; p < 0.001). All individual parameters (Items 1 to 8) were also significantly improved from baseline after 6 weeks of IQP-AO-101 intake. Analysis of variance with baseline values as covariates showed statistically significant improvements across all individual parameters for IQP-AO-101 when compared to placebo. The measurements using the activity tracker, sleep diary, FAIR-2, and POMS did not reveal any significant differences between groups. No adverse effects related to the intake of IQP-AO-101 were reported. Tolerability was rated as very good by all the subjects and by the investigator for all cases.
Conclusions: In this study, IQP-AO-101 was well tolerated and efficacious for promoting sleep and enhancing daytime performance in subjects with moderate sleep disturbances.
Clinical Trial Registration: This trial is registered with ClinicalTrials.gov, no. NCT03114696.
Material and Method: A single center retrospective study with a review of medical records was performed involving 105 patients, who were surgically treated for ruptured intracranial aneurysms in the Sultanah Aminah Hospital, in Johor Bahru, from July 2011 to January 2016. Information collected was the patient demographic data, Glasgow Coma Scale (GCS) prior to surgery, World Federation of Neurosurgical Societies Scale (WFNS), subarachnoid hemorrhage (SAH) grading system, and timing between SAH ictus and surgery. A good clinical grade was defined as WFNS grade I-III, whereas, WFNS grades IV and V were considered to be poor grades. The outcomes at discharge and six months post surgery were assessed using the modified Rankin's Scale (mRS). The mRS scores of 0 to 2 were grouped into the "favourable" category and mRS scores of 3 to 6 were grouped into the "unfavourable" category. Only cases of proven ruptured aneurysmal SAH involving anterior circulation that underwent surgical clipping were included in the study. The data collected was analysed using the Statistical Package for Social Sciences (SPSS). Univariate and multivariate analyses were performed and aP-value of < 0.05 was considered to be statistically significant.
Result: A total of 105 patients were included. The group was comprised of 42.9% male and 57.1% female patients. The mean GCS of the patients subjected to surgical clipping was 13, with the majority falling into the good clinical grade (78.1%). The mean timing of the surgery after SAH was 5.3 days and this was further categorised into early (day one to day three, 45.3%), intermediate (day four to day ten, 56.2%), and late (after day ten, 9.5%). The total favourable outcome achieved at discharge was 59.0% as compared to 41.0% of the unfavourable outcome, with an overall mortality rate of 10.5%. At the six-month post surgery review (n= 94), the patients with a favourable outcome constituted 71.3% as compared to 28.7% with an unfavourable outcome. The mortality, six months post surgery was 3.2%. On a univariate analysis of early surgical clipping, patients with a better GCS and good clinical grade had a significantly better outcome at discharge. Based on the univariate study, six months post surgery, the timing of the surgery and the clinical grade remained significant predictors of the outcome. On the basis of the multivariate analysis, male patients of younger age, with a good clinical grade, were associated with favourable outcomes, both at discharge and six months post surgery.
Conclusion: In this study, we concluded that younger male patients with a good clinical grade were associated with a favourable outcome both at discharge and six months post surgery. We did not find the timing of the surgery, size of the aneurysm or duration of surgery to be associated with a patient's surgical outcome. Increasing age was not associated with the surgical outcome in a longer term of patient's follow up.
METHODS: Short duration guided deep breathing videos consisting of 5, 7 and 9 min respectively were created and used on subjects training. The effect on cognitive control was assessed using a Go/NoGo task along with event-related potential (ERP) measurements at Fz, Cz, and Pz.
RESULTS: From the study, the significant outcome showed at the follow-up session in which participants engaged for 5 min deep breathing group showed a profound NoGo N2 amplitude increment as compared to the control group, indicating an enhanced conflict monitoring ability. An inverse relationship between the NoGo N2 amplitude and the breathing duration is observed as well at the follow-up session.
CONCLUSION: These results indicated the possibility of performing short duration deep breathing guided by a video to achieve an enhanced conflict monitoring as an alternative to other mindfulness practices and 5 min is found to be the optimum practice duration.
SIGNIFICANT: This study is the first to establish a relationship between deep breathing and conflict monitoring through ERP. The study population of young adults taken from the same environment reduces the variance in ERP results due to age and environment.
LIMITATION: A larger sample size would provide a greater statistical power. A longer duration of deep breathing should be investigated to further clarify the relationship between the practice duration and the NoGo N2 amplitude. The result can be split by gender and analyzed separately due to the different brain structure of males and females.