Zolpidem's Effects on Road Cycling Performance

January 23, 2025 updated by: National Taiwan Normal University

The Impact of the Sedative-Hypnotic Medication Zolpidem on Performance in Road Cycling

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 320
        • Ten-Chan General hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Placebo
10 mg starch
Other: Placebo
Starch 10 mg tablet (taken before bedtime)
Experimental: Drug
10 mg Zolpidem
Drug: Zolpidem 10 mg
Zolpidem tartrate 10 mg tablet (taken before bedtime)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan Normal University

Collaborators

Ten-Chen General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2024

Primary Completion (Actual)

December 22, 2024

Study Completion (Actual)

December 29, 2024

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

January 23, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 113-A-01-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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