Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
15 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-06-26
Study Completion Date
2024-12-29
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Healthy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
CROSSOVER
Primary Study Purpose
BASIC_SCIENCE
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
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Placebo
10 mg starch
Group Type
OTHER
Placebo
Intervention Type
OTHER
Starch 10 mg tablet (taken before bedtime)
Drug
10 mg Zolpidem
Group Type
EXPERIMENTAL
Zolpidem 10 mg
Intervention Type
DRUG
Zolpidem tartrate 10 mg tablet (taken before bedtime)
Interventions
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Zolpidem 10 mg
Zolpidem tartrate 10 mg tablet (taken before bedtime)
Intervention Type
DRUG
Placebo
Starch 10 mg tablet (taken before bedtime)
Intervention Type
OTHER
Eligibility Criteria
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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
* 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
* Individuals with medical, psychiatric, and sleep disorders
Minimum Eligible Age
20 Years
Eligible Sex
MALE
Accepts Healthy Volunteers
No
Sponsors
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Ten-Chen General Hospital
OTHER
Sponsor Role
collaborator
National Taiwan Normal University
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Locations
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Ten-Chan General hospital
Taoyuan District, Taiwan, Taiwan
Site Status
Countries
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Taiwan
References
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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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
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.
Reference Type
BACKGROUND
Other Identifiers
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113-A-01-02
Identifier Type: -
Identifier Source: org_study_id
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