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| Name | Class |
|---|---|
| Ten-Chen General Hospital | OTHER |
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This study will recruit 15 healthy participants who regularly engage in cycling as their primary physical activity. Recruitment will take place at the hospital, where participants will sign an informed consent form and complete a health survey. The experiments will be conducted at the Exercise Physiology Laboratory in Gongguan, National Taiwan Normal University. Participants will need to familiarize themselves with the procedures before the formal tests. Prior to the measurements, participants must complete: (1) a Sleep Quality Questionnaire and (2) a Sleep Pattern Questionnaire.
This study follows a double-blind design and involves two formal experiments. Two weeks before the experiments, participants will complete forms regarding sleep quality, recent Functional Threshold Power (FTP) over the past 1-2 months, and will receive an explanation of the study. One week before the experiments, participants will visit Dr. Kuo-Yi Weng at the Rheumatology and Immunology Clinic of Zhongli Ten-Chan Hospital to obtain the study medication, Zolpidem .
On the evening before the first experiment, participants will report to the laboratory before 7:00 PM. At 8:59 PM, they will be randomly assigned to take either 10 mg of Zolpidem or a placebo. At 9:00 PM, participants will go to bed wearing a sleep monitoring device (Fitbit Charge 4). At 4:00 AM, they will wake up, complete the Leeds Sleep Evaluation Questionnaire (Self-reported), and have breakfast. The formal experiment will begin at 5:00 AM, during which participants will use the Zwift online platform to simulate a 60-kilometer ride to measure athletic performance. The two formal experiments will be spaced one week apart.
1. Specimen Collection:
2. Prohibitions, Restrictions, and Requirements for Participants During the Trial:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Other | 10 mg starch |
|
| Drug | Experimental | 10 mg Zolpidem |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolpidem 10 mg | Drug | Zolpidem tartrate 10 mg tablet (taken before bedtime) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Physiological Indicator (Lactate) for 40km at 70%FTP | Lactate in mmol/L .Testing will be conducted using an indoor trainer (TACX NEO) to assess whether taking medication affects lactate changes.Lactate will be collected at 10, 20, 30, 40 kilometers, respectively. A total of four times. | Approximately 1 to 1.5 hours during each study intervention. |
| Physiological Indicator (Blood Glucose) for 40km at 70%FTP | Glucose in mg/dL . Testing will be conducted using an indoor trainer (TACX NEO) to evaluate whether taking medication affects blood glucose changes.The evaluation will be conducted when the participants complete 10, 20, 30, and 40 km of cycling(Using CGM). A total of four times. | Approximately 1 to 1.5 hours during each study intervention. |
| Rate of Perceived Exertion for 40 km at 70% FTP | Borg Scale (6-20) .Testing will be conducted using an indoor trainer (TACX NEO) to determine whether taking medication influences changes in the Rate of Perceived Exertion (RPE).The evaluation will be conducted when the participants complete 10, 20, 30, and 40 km of cycling. A total of four times. | Approximately 1 to 1.5 hours during each study intervention. |
| 20KM Time Trial | Time trial (minute) .Testing will be conducted using an indoor trainer (TACX NEO) to assess whether taking medication affects the time trial (TT) performance.Participants performed a 20 km time trial (TT) after completing 40 km at 70% FTP, and the completion time was recorded.A total of one times. | Approximately 30 to 60 min during each study intervention. |
| Average Power for 20KM Time Trial | Average Power(W).Testing will be conducted using an indoor trainer (TACX NEO) to evaluate whether taking medication affects the average power output.Participants performed a 20 km time trial (TT) after completing 40 km at 70% FTP, and the average power was recorded.A total of one times. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ten-Chan General hospital | Taoyuan | Taiwan | 320 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30807636 | Result | Wilms B, Chamorro R, Hallschmid M, Trost D, Forck N, Schultes B, Molle M, Sayk F, Lehnert H, Schmid SM. Timing Modulates the Effect of Sleep Loss on Glucose Homeostasis. J Clin Endocrinol Metab. 2019 Jul 1;104(7):2801-2808. doi: 10.1210/jc.2018-02636. | |
| 23760468 | Result | Temesi J, Arnal PJ, Davranche K, Bonnefoy R, Levy P, Verges S, Millet GY. Does central fatigue explain reduced cycling after complete sleep deprivation? Med Sci Sports Exerc. 2013 Dec;45(12):2243-53. doi: 10.1249/MSS.0b013e31829ce379. |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Other |
Starch 10 mg tablet (taken before bedtime) |
|
| Approximately 30 to 60 min during each study intervention. |
| Physiological Indicator (Blood Glucose) for 20KM Time Trial | Glucose in mg/dl . Testing will be conducted using an indoor trainer (TACX NEO) to assess whether taking medication affects blood glucose changes during the time trial.The evaluation will be conducted when the participants complete 10, 20 km of Time Trial. A total of two times. | Approximately 30 to 60 min during each study intervention. |
| Physiological Indicator (Lactate) for 20KM Time Trial | Testing will be conducted using an indoor trainer (TACX NEO) to evaluate whether taking medication affects lactate changes during the time trial.The evaluation will be conducted when the participants complete 10, 20 km of Time trial . A total of two times . | Approximately 30 to 60 minutes during each study intervention. |
| Rate of Perceived Exertion for 20km Time trial | RPE：Borg Scale (Score：6-20 ).Testing will be conducted using an indoor trainer (TACX NEO) to determine whether taking medication influences changes in the Rate of Perceived Exertion (RPE) during the time trial.The evaluation will be conducted when the participants complete 10, 20 km of Time trial . A total of two times . | Approximately 30 to 60 minutes during each study intervention. |
| Sleep Duration (Minutes) | Sleep Duration in Minutes.Sleep duration will be measured using Fitbit Charge 4 to evaluate the differences in sleep length between taking and not taking medication.Measurements will begin after taking medication at 9:00 PM and conclude upon waking up the next day at 4:00 AM. Sleep duration will be recorded using Fitbit Charge 4. | The monitoring duration is 7 hours during each study intervention. |
| Sleep Latency (Minutes): | Sleep latency in minutes . Sleep latency will be measured using Fitbit Charge 4 to evaluate the differences in the time taken to fall asleep between taking and not taking medication.Measurements will begin after taking medication at 9:00 PM and conclude upon waking up the next day at 4:00 AM. Sleep potency will be recorded using Fitbit Charge 4. | The monitoring duration is 7 hours during each study intervention. |
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