Zolpidem's Effects on Road Cycling Performance

Phase 4

Completed

• Conditions: Healthy
• Interventions: Other: Placebo; Drug: Zolpidem 10 mg

• Registration Number: NCT06800378
• Lead Sponsor: National Taiwan Normal University

Brief Summary

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.

Detailed Description

1. Specimen Collection:

1. On the test day, arm tissue glucose levels will be collected using continuous glucose monitoring (CGM), which will continue until the experiment concludes.

2. Fingerstick blood samples will be taken using a lancet to measure glucose and lactate levels at 0,10,20,40,50 and 60 kilometers.

2. Prohibitions, Restrictions, and Requirements for Participants During the Trial:

1. Training and Sleep Patterns: Participants are required to maintain their usual training routines and sleep patterns without changing their schedules increasing training intensity. This is to control for changes in physical performance and sleep quality during the trial period.

2. Diet: Participants should consume the same or similar foods the day before and the day of the trial to minimize the impact of dietary changes on the experiment. 3.Restrictions: Participants are prohibited from consuming caffeinated beverages such as tea, coffee, or energy drinks on the night before and the morning of the trial to avoid potential interference with the results.

Study Timeline

• Study Start: 2024-06-26
• Primary Completion: 2024-12-22
• Study First Submitted: 2024-12-23
• Study Completion: 2024-12-29
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-30
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 15

Inclusion Criteria

• Adults over 20 years old
• Bicycle age over 2 years
• Rides more than twice a week
• Does not regularly use sedative-hypnotic drugs or first-generation antihistamines that aid in sleep
• Does not have drinking or smoking habits (≤1 time per week)
• Has competition experience (has participated in cycling competitions over 100 kilometers or other cycling races)
• Has used an indoor bicycle trainer
• Average sleep time is between 11:00 PM and 1:00 AM

Exclusion Criteria

• Irregular sleep and shift workers
• Individuals with medical, psychiatric, and sleep disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	10 mg starch
Drug	Zolpidem 10 mg	10 mg Zolpidem

Primary Outcome Measures

Name	Time	Method
Physiological Indicator (Lactate) for 40km at 70%FTP	Approximately 1 to 1.5 hours during each study intervention.	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.
Physiological Indicator (Blood Glucose) for 40km at 70%FTP	Approximately 1 to 1.5 hours during each study intervention.	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.
Rate of Perceived Exertion for 40 km at 70% FTP	Approximately 1 to 1.5 hours during each study intervention.	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.
20KM Time Trial	Approximately 30 to 60 min during each study intervention.	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.
Average Power for 20KM Time Trial	Approximately 30 to 60 min during each study intervention.	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.
Physiological Indicator (Blood Glucose) for 20KM Time Trial	Approximately 30 to 60 min during each study intervention.	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.
Physiological Indicator (Lactate) for 20KM Time Trial	Approximately 30 to 60 minutes during each study intervention.	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 .
Rate of Perceived Exertion for 20km Time trial	Approximately 30 to 60 minutes during each study intervention.	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 .
Sleep Duration (Minutes)	The monitoring duration is 7 hours during each study intervention.	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.
Sleep Latency (Minutes):	The monitoring duration is 7 hours during each study intervention.	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.

Trial Locations

Locations (1)

Ten-Chan General hospital; 🇨🇳 Taoyuan, Taiwan