PSY/285
I have chosen to describe the study to be performed by the pharmaceutical company that wants to test a new sleep aid. Before they engage in human studies the researchers must determine what they want to prove exactly. Since the goal of the drug is to promote better sleep habits, the hypothesis for this study would be that individuals taking this new aid will fall asleep faster and stay asleep longer than they did before they started taking the drug. Randomization of the subjects involved in the study is important in order for the results of the variable to be accurate when measured, however there are some ethical considerations that must be addressed first. Since the controlled sleep
aid is a drug and with any drug there may be certain side effects, individuals under the age of 18 are not permitted to participate in the trial. Those individuals over the age of 18 who are signed up to participate in the sleep study were given an extensive medical background check to make sure they were not allergic to any medications that might be found in the drug. They were also provided with all the information on the drug including possible side effects and dependency. Once all the prerequisites are met the group of 20 participants varying in weight, age, gender, and nationality are randomly divided into two groups of 10. One group will be a controlled group meaning they will be observed sleeping as they normally would and the other group is the treatment group and will be taking the sleep aid in a normally prescribed dose. Both groups, however, will be given a supplement every night at bedtime in order to achieve experimental realism. Neither group is aware that any placebo is involved. The study will last a total of two weeks, during the first week both groups are placed in similar dorms and are observed sleeping every night without the help of any medications. This not only allows time for the subjects to become acclimated to their new surroundings, it also gives researchers a point of reference as to how the subjects slept before starting on the medication. Every morning the time it took them to fall asleep and the length of time that they slept is documented for each individual and at the end of the first week they are given a survey of how well they think they slept and if these sleep habits compare to their normal sleep habits at home. Administration of the medication begins at the beginning of the second week. The treatment group receives the drug and the control group receives placebo. They are observed for another week under the same conditions, in the same dorm and documented the same way. At the end of the second week they are asked to take the same survey and give their opinion of the drug. All data from both groups is collected and the results from each group is compared to see if the drug made a positive and significant difference on the sleep the individuals received while they we on it. The first step in finding out the results of the trial is to measure the sleep of the individuals with no medication and compare the results to the sleep they received during the second week. Then they compared that data to the sleep those individuals on placebo received. The results showed that those individuals on placebo complained that they did not sleep any better or worse on the drug. The treatment group showed longer periods of sleep while on the drug and only complained of a little grogginess in the morning. There was no change however in the time it took either group to fall asleep on or off the drug. The results of the sleep study indicate that while individuals did experience longer periods of sleep, the drug did not aid them in falling sleep faster whatsoever. Therefore only half of the hypothesis proved true based on the outcome of the trial.