Clinical trial NCT06800378: Zolpidem's Effects on Road Cycling Performance
Official title: The Impact of the Sedative-Hypnotic Medication Zolpidem on Performance in Road Cycling
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
Collaborators: name: Ten-Chen General Hospital
First posted: 2025-01-30
Enrollment: 15
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Physiological Indicator (Lactate) for 40km at 70%FTP
timeFrame: Approximately 1 to 1.5 hours during each study intervention.
measure: Physiological Indicator (Blood Glucose) for 40km at 70%FTP
timeFrame: Approximately 1 to 1.5 hours during each study intervention.
measure: Rate of Perceived Exertion for 40 km at 70% FTP
timeFrame: Approximately 1 to 1.5 hours during each study intervention.
measure: 20KM Time Trial
timeFrame: Approximately 30 to 60 min during each study intervention.
measure: Average Power for 20KM Time Trial
timeFrame: Approximately 30 to 60 min during each study intervention.
measure: Physiological Indicator (Blood Glucose) for 20KM Time Trial
timeFrame: Approximately 30 to 60 min during each study intervention.
measure: Physiological Indicator (Lactate) for 20KM Time Trial
timeFrame: Approximately 30 to 60 minutes during each study intervention.
measure: Rate of Perceived Exertion for 20km Time trial
timeFrame: Approximately 30 to 60 minutes during each study intervention.
measure: Sleep Duration (Minutes)
timeFrame: The monitoring duration is 7 hours during each study intervention.
measure: Sleep Latency (Minutes):
timeFrame: The monitoring duration is 7 hours during each study intervention.
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Ten-Chan General hospital
Study officials:
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