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Zolpidem's Effects on Road Cycling Performance

NCT06800378 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-01-30

No results posted yet for this study

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.

Conditions

  • Healthy

Interventions

DRUG

Zolpidem 10 mg

Zolpidem tartrate 10 mg tablet (taken before bedtime)

OTHER

Placebo

Starch 10 mg tablet (taken before bedtime)

Sponsors & Collaborators

  • Ten-Chen General Hospital

    collaborator OTHER

  • National Taiwan Normal University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-26
Primary Completion
2024-12-22
Completion
2024-12-29

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06800378 on ClinicalTrials.gov