Clenbuterol bei der Amyotrophen Lateralsklerose Kein Hinweis für einen positiven Effekt Der Nervenarzt Springer Nature Link
Repeated recording of heart rhythm parameters, such as the heart rate (HR), provides clinically relevant information on the effects of a novel drug intervention. The asleep HR estimates were most repeatable and sensitive to treatment effects. The second arbitrary choice we made in this study is that we assumed patients to be awake between 9 AM and 9 PM when sleep states were missing during the night. However, smartwatches can easily be integrated in such trials for continuous monitoring of participants who go about their daily routines.
superweb and orange triangles indicate the HR in the placebo arm and the clenbuterol arm, respectively. Post hoc comparisons between postdose and averaged predose heart rates (mean difference ± SE). No changes in HR were detected for any of the markers in the placebo group. Post hoc comparisons between the average baseline HR and HR during treatment days are presented in Table 4 and in Figure 2. For the patients in the clenbuterol group, 4 out of 44 nights were missing prior to dosing and 6 out of 48 nights were missing post dosing. The intercept and day (ie, day –6 to day 0) were included as fixed effects.
Patients wore the smartwatch at least 6 days prior to the treatment period (ie, day –6 to day 0) and continued wearing the smartwatch during the treatment period (ie, day 0 to day 6). The app was configured to work with the smartwatch and connected to an account that was used to upload the measurements during the study days. Here, we report the exploratory objective of evaluating the effects of clenbuterol, a direct-acting sympathomimetic with predominant β2-adrenoceptor selectivity, on HR measured with a smartwatch. The work presented here was part of a trial aimed at demonstrating the central nervous system effects of the drug. Then, after evaluating the repeatability of smartwatch-obtained HR over a time period of 1 week, we present the sensitivity of the smartwatch to detect drug-induced changes in the HR. Here, we evaluate the feasibility of using a smartwatch-based HR monitor in a clinical trial.
For days with missing sleep states, the awake period was assumed to start at 9 AM and end at 9 PM. The HR while awake is defined as all HR samples collected outside the asleep boundaries. For further processing steps, we distinguished between the HR while asleep and the HR while awake. g-r-s captured HR for 1 week prior to treatment and 1 week after treatment (ie, day –6 to day 6). Data collected by the smartwatch include estimates of the HR and sleep states.
The data were collected as part of a multiple-dose, investigator-blinded, randomized, placebo-controlled, parallel-group study of 12 patients with Parkinson disease. These include increased heart rate, muscular tremors, headaches, nausea, fever, and chills. One issue is that clenbuterol is a food contaminant in some countries; doping control must distinguish between accidental and deliberate intake.
Since the tablets of clenbuterol and placebo were nonmatching, patients were instructed not to discuss the tablet appearance with other patients or study site staff. The clenbuterol dose was titrated from 20 µg on the first treatment day (ie, day 0) to 40 µg on day 1 and 80 µg on days 2 through 6. The study duration was approximately 7 weeks, including a screening period of up to 31 days, but a minimum of 6 days (day –6 to day 0), a treatment period of 1 week (day 0 to day 6), and a 1-week follow-up period. However, while the estimated sleep duration can be considered reasonably reliable, estimates of the substates (eg, light or deep sleep) cannot .
From here on, serpolicia will be referred to as Awake-Low, Awake-Median, Awake-High, Asleep-Low, Asleep-Median, and Asleep-High. During the screening session, patients were given a smartwatch and the Withings Health Mate app was installed on their phones. Patients were dosed with either clenbuterol or a matching number of tablets of placebo. This was a multiple-dose, investigator-blinded, randomized, placebo-controlled, parallel group study. The trial included patients at a Hoehn and Yahr stage between 1 and 3 and a Mini Mental Status Examination score of above 25.