Up to healthy volunteers will be enrolled to participate in the 10 day study. Days 8 - 10 will take place at Moffitt Hospital. On Day 10, subjects will take one dose of either almorexant mg, almorexant mg, zolpidem 10mg, or placebo. Cognitive tests will be administered to subjects throughout Day Subjects will return for follow-up safety labs within 5 - 12 days of dosing with study medication. Based on animal studies, it is anticipated that subjects who take almorexant will be less cognitively impaired than those who take zolpidem.
FDA Resources. Arms and Interventions. Subjects will receive a one-time dose of Almorexant mg. Subjects will receive a one-time dose of Zolpidem 10mg. Outcome Measures. Primary Outcome Measures : A comparison between dosing groups on performance on neurocognitive measures [ Time Frame: Within a 7-hour window post dose. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.
To participate in the study, participants must: Be between the ages of 19 and 39 Be in good physical health Be a good sleeper with consistent bedtimes and wake times Not have problems falling or staying asleep Be a non-smoker Meet our other study criteria. Contacts and Locations. Any prosthetic devices e. Medications affecting cognition or sleep. Presence of any known or suspected obstructive disease of the gastrointestinal tract, including but not limited to diverticulitis and inflammatory bowel disease.
History of disorders or impairment of the gag reflex. Previous gastrointestinal surgery. Previous felinization of the esophagus. Subjects hypomotility disorders of the gastrointestinal tract including but not limited to Ileus. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Orexin Core Body Temperature. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Recruitment status was: Active, not recruiting First Posted : February 28, Last Update Posted : February 28, Study Description.
Background: Attention deficit hyperactivity disorder ADHD is an early onset, highly heritable, clinically heterogeneous, long-term impairing disorder with tremendous impact on individuals, families, and societies.
It affects 7. Emerging evidence has suggested that patients with ADHD may present with a deficit of attention, alertness and sleep disturbances.
Height was measured using a wall-mounted stadiometer, and was recorded to the nearest 0. The patients' weight was measured with only light clothing using a calibrated digital scale Beurer, GS49, Germany , and was documented to the nearest 0. Patients were stratified into normal weight, overweight, and obese according to WHO criteria. Waist circumference was measured at the end of normal expiration mid-way between the lower costal margin and anterior superior iliac crest, and was recorded to the nearest 0.
After the patients had relaxed for about 10 minutes, two readings of systolic and diastolic blood pressures were obtained from each patient within a 5-min interval using a standard sphygmomanometer Riester, Big Ben adults, Germany. Patients were instructed to perform a hour overnight fast; fasting blood was obtained the next day. Additionally, in all patients, a standard 75 g fasting oral glucose tolerance test was performed, and two blood draws were conducted at 60 and minutes.
Orexin concentrations were obtained at time zero and at minutes. Serum insulin and fasting plasma glucose FPG were determined at times 0, 60, and minutes. All other laboratory parameters were determined at baseline only.
Using a similar protocol, three months after initiation of treatment, a second fasting blood draw was performed.
Serum concentrations of FPG were determined using the glucose oxidize method. The insulin sensitivity index derived from this equation correlates strongly with the direct measurement obtained using the euglycemic insulin clamp [ 24 ].
Serum concentrations of lipids including total cholesterol, low density lipoprotein LDL cholesterol, high density lipoprotein HDL cholesterol, and triglycerides were measured with enzymatic methods Pars Azmun commercial kits, Karaj, Iran. All analyses were performed using the statistical package for social sciences SPSS version Continuous variables with non-normal distributions were expressed as median interquartile range.
A logarithmic transformation was carried out to obtain normality, and hence to make parametric statistical tests plausible. Comparisons of the mean levels of continuous variables across two categories were performed using the independent t -test. With more than two categories, analysis of variance ANOVA was employed and the p-value for the linear trend was calculated.
The distribution of categorical variables across categories was assessed using the Chi-squared test. Associations between two continuous variables were evaluated using partial correlation and adjustment for the effects of possible confounders i. The within-group changes in continuous variables between baseline and after three months, or before and after OGTT, were investigated using the paired t -test.
The between-group efficacy of continuous variables between baseline and after three months was investigated using analysis of covariance ANCOVA. As the serum sample of one of the patients in the pioglitazone arm was missing, 59 patients 30 in the metformin arm and 29 in the pioglitazone arm were included in the final analysis. The mean age of the participants was Women represented Legend: Variables with non-normal distributions are presented as median interquartile range followed by their log-transformed values.
Two patients in the metformin arm 6. They were advised to change the time of taking the medication. No significant adverse events requiring medication discontinuation were observed for either arm of the trial, and all patients were able to tolerate the prescribed doses. As a result, no dose titration or switching of medication was necessary.
Mean orexin concentrations at baseline were 0. Orexin concentration in the youngest age quartile was about 2. Legend: P-value for linear trend is calculated for age and general obesity. Following OGTT, serum orexin concentrations significantly decreased from 0.
Given the strong association between orexin concentration and age, all correlations are adjusted for age. Patients in the pioglitazone arm were on average 5. The mean baseline orexin concentrations in metformin and pioglitazone arms were 0. No significant changes in waist circumference and BMI were noted. Legend: Variables with non-normal distribution were log-transformed. Variables with non-normal distributions are log-transformed. Our observations show a negative association between peripheral orexin and insulin resistance.
Before discussing the main findings in detail, a few corollary observations deserve mention. Orexin concentrations were negatively associated with age. In the youngest age category, orexin concentrations were more than twofold higher than in patients in the oldest age category.
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