Zolpidem's Effects on Road Cycling Performance

NCT06800378 | Completed Phase 4

• 1 other identifier: 113-A-01-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

Study Arms (2)

Placebo

OTHER

10 mg starch

Other: Placebo

Drug

EXPERIMENTAL

10 mg Zolpidem

Drug: Zolpidem 10 mg

Interventions

Zolpidem 10 mg DRUG

Zolpidem tartrate 10 mg tablet (taken before bedtime)

Drug

Placebo OTHER

Starch 10 mg tablet (taken before bedtime)

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan Normal University: lead
• Ten-Chen General Hospital: collaborator

Study Sites (1)

Ten-Chan General hospital

Taoyuan District, Taiwan, 320, Taiwan

Location

Related Publications (17)

• 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.

  PMID: 30807636 BACKGROUND

• 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.

  PMID: 23760468 BACKGROUND

• Saner NJ, Lee MJ, Kuang J, Pitchford NW, Roach GD, Garnham A, Genders AJ, Stokes T, Schroder EA, Huo Z, Esser KA, Phillips SM, Bishop DJ, Bartlett JD. Exercise mitigates sleep-loss-induced changes in glucose tolerance, mitochondrial function, sarcoplasmic protein synthesis, and diurnal rhythms. Mol Metab. 2021 Jan;43:101110. doi: 10.1016/j.molmet.2020.101110. Epub 2020 Oct 31.

  PMID: 33137489 BACKGROUND

• Rosenberg RP, Hull SG, Lankford DA, Mayleben DW, Seiden DJ, Furey SA, Jayawardena S, Roth T. A randomized, double-blind, single-dose, placebo-controlled, multicenter, polysomnographic study of gabapentin in transient insomnia induced by sleep phase advance. J Clin Sleep Med. 2014 Oct 15;10(10):1093-100. doi: 10.5664/jcsm.4108.

  PMID: 25317090 BACKGROUND

• Papanikolaou DD, Astara K, Vavougios GD, Daniil Z, Gourgoulianis KI, Stavrou VT. Elements of Sleep Breathing and Sleep-Deprivation Physiology in the Context of Athletic Performance. J Pers Med. 2022 Mar 2;12(3):383. doi: 10.3390/jpm12030383.

  PMID: 35330382 BACKGROUND

• Mougin F, Simon-Rigaud ML, Davenne D, Renaud A, Garnier A, Kantelip JP, Magnin P. Effects of sleep disturbances on subsequent physical performance. Eur J Appl Physiol Occup Physiol. 1991;63(2):77-82. doi: 10.1007/BF00235173.

  PMID: 1748108 BACKGROUND

• Leong RLF, Cheng GH, Chee MWL, Lo JC. The effects of sleep on prospective memory: A systematic review and meta-analysis. Sleep Med Rev. 2019 Oct;47:18-27. doi: 10.1016/j.smrv.2019.05.006. Epub 2019 May 31.

  PMID: 31216498 BACKGROUND

• Horoszok L, Baleeiro T, D'Aniello F, Gropper S, Santos B, Guglietta A, Roth T. A single-dose, randomized, double-blind, double dummy, placebo and positive-controlled, five-way cross-over study to assess the pharmacodynamic effects of lorediplon in a phase advance model of insomnia in healthy Caucasian adult male subjects. Hum Psychopharmacol. 2014 May;29(3):266-73. doi: 10.1002/hup.2395.

  PMID: 24911577 BACKGROUND

• Holgado D, Manresa-Rocamora A, Zamboni L, Lugoboni F, Peiro AM, Zandonai T. The effect of benzodiazepines on exercise in healthy adult participants: A systematic review. J Addict Dis. 2022 Jul-Sep;40(3):336-344. doi: 10.1080/10550887.2021.1990640. Epub 2021 Nov 9.

  PMID: 34751107 BACKGROUND

• Haraldsdottir K, Sanfilippo J, McKay L, Watson AM. Decreased Sleep and Subjective Well-Being as Independent Predictors of Injury in Female Collegiate Volleyball Players. Orthop J Sports Med. 2021 Sep 9;9(9):23259671211029285. doi: 10.1177/23259671211029285. eCollection 2021 Sep.

  PMID: 34527756 BACKGROUND

• Grobler LA, Schwellnus MP, Trichard C, Calder S, Noakes TD, Derman WE. Comparative effects of zopiclone and loprazolam on psychomotor and physical performance in active individuals. Clin J Sport Med. 2000 Apr;10(2):123-8. doi: 10.1097/00042752-200004000-00007.

  PMID: 10798794 BACKGROUND

• Gramaglia E, Ramella Gigliardi V, Olivetti I, Tomelini M, Belcastro S, Calvi E, Dotta A, Ghigo E, Benso A, Broglio F. Impact of short-term treatment with benzodiazepines and imidazopyridines on glucose metabolism in healthy subjects. J Endocrinol Invest. 2014 Feb;37(2):203-6. doi: 10.1007/s40618-013-0016-y. Epub 2014 Jan 9.

  PMID: 24497220 BACKGROUND

• Craven J, McCartney D, Desbrow B, Sabapathy S, Bellinger P, Roberts L, Irwin C. Effects of Acute Sleep Loss on Physical Performance: A Systematic and Meta-Analytical Review. Sports Med. 2022 Nov;52(11):2669-2690. doi: 10.1007/s40279-022-01706-y. Epub 2022 Jun 16.

  PMID: 35708888 BACKGROUND

• Collomp K, Fortier M, Cooper S, Long A, Ahmaidi S, Prefaut C, Wright F, Picot M, Cote MG. Performance and metabolic effects of benzodiazepine during submaximal exercise. J Appl Physiol (1985). 1994 Aug;77(2):828-33. doi: 10.1152/jappl.1994.77.2.828.

  PMID: 8002535 BACKGROUND

• Chase JD, Roberson PA, Saunders MJ, Hargens TA, Womack CJ, Luden ND. One night of sleep restriction following heavy exercise impairs 3-km cycling time-trial performance in the morning. Appl Physiol Nutr Metab. 2017 Sep;42(9):909-915. doi: 10.1139/apnm-2016-0698. Epub 2017 May 3.

  PMID: 28467857 BACKGROUND

• Boonstra TW, Stins JF, Daffertshofer A, Beek PJ. Effects of sleep deprivation on neural functioning: an integrative review. Cell Mol Life Sci. 2007 Apr;64(7-8):934-46. doi: 10.1007/s00018-007-6457-8.

  PMID: 17347797 BACKGROUND

• Azboy O, Kaygisiz Z. Effects of sleep deprivation on cardiorespiratory functions of the runners and volleyball players during rest and exercise. Acta Physiol Hung. 2009 Mar;96(1):29-36. doi: 10.1556/APhysiol.96.2009.1.3.

  PMID: 19264040 BACKGROUND

MeSH Terms

Interventions

Zolpidem

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: January 30, 2025
• Study Start: June 26, 2024
• Primary Completion: December 22, 2024
• Study Completion: December 29, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)