Altitude Training Effectiveness; Is There a Role for Sleep and Menstrual Health?
NCT ID: NCT07337928
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
30 participants
OBSERVATIONAL
2026-02-28
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Effect of Mental Fatigue on the Cerebral Oxygenation During Endurance Exercise
NCT05355493
HighCycle Study: Effect of High Altitude on Acute Mountain Sickness in Women Related to Their Menstrual Cycle Phase
NCT06499714
Short or Long High Intensity Training
NCT04075929
Acute and Chronic Responses to Blood Pressure After Exercise
NCT03160989
Effect of High Altitude Exposure, Acclimatization and Re-exposure on Psychomotor Performance in Lowlanders
NCT02731456
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The overall effectiveness of altitude training to improve performance is backed up by a significant amount of scientific data. Nonetheless, up to date, the efficacy of altitude training is still questioned by some, due the lack of rigorous and well-controlled investigations, and no scientific consensus exists. Since Lundby and colleagues published their critical views on the general application of altitude training to enhance performance in elite athletes, follow-up research has substantiated these critical views of Lundby and colleagues. Nevertheless, the debate on the usefulness of altitude training in elite athletes is still ongoing, and currently revolves around whether athletes with an already high hemoglobin mass (i.e., elite athletes) can successfully increase their hemoglobin mass via altitude training.
A topic that could provide some new insights is the issue of intra- and interindividual variability in the response to altitude training, and the underlying mechanisms of these variabilities. Multiple studies have been performed that clearly outline the presence of both intra- and interindividual variability in the response to altitude training. The determination and evaluation of all state and trait-specific factors that could influence an athlete's response to altitude training is cur-rently ongoing. Nummela et al. showed that the mean effectiveness of altitude training in yielding an increase in hemoglobin mass could rise from 56% to 69% when targeting altitude exposure (2,000-2,500 m), iron deficiency and inflammation as moderating state factors. This emphasizes the need to carefully consider all the possible moderating state factors that may influence an athlete's response to altitude training. Furthermore, these findings stress the need for future research to describe more accurately how these different influencing state factors (and potential oth-er state and trait factors) interact to impact the altitude training-response in both elite and recrea-tional athletes.
One of these potentially crucial factors that could play a role in the effectiveness of altitude training to trigger performance-improving adaptations is sleep. Sleep is one of the most important aspects of recovery, and nowadays it is recommended to stay below 3,000 m (or an equivalent normobaric reduction of inspired O2) at night in altitude training paradigms. This recommendation is based on the fact that sleep is impaired at high altitude, and impaired sleep could counteract the positive physiological responses that are aimed for, certainly when it is prolonged for \~2-3 weeks (i.e., the current suggested optimal hypoxic dose, taking into account altitude and exposure time \[1\]). However, the guideline to stay below 3,000 m to prevent altitude-induced sleep impairments might be inadequate. Hoshikawa et al. demonstrated that acute exposure to normobaric hypoxia equivalent to a 2,000 m altitude decreased slow-wave sleep in athletes, but it did not change subjective sleepiness or amounts of urinary catecholamines. These results point out that the athlete's sleep might be disturbed even at moderate altitudes of 2,000 m and, more importantly, that athletes are not aware of it (i.e., subjective sleepiness did not change). Moreover, the study of Hoshikawa et al. also revealed that the apnea/hypopnea index (AHI; i.e., the number of signif-icant respiratory events qualifying as apnea or hypopnea per hour of sleep) increased in hypoxia compared to normoxia, and the magnitude of this effect varied widely among participants (i.e., high interindividual variability). This high interindividual variability might be associated with the interindividual variability that is observed in altitude training effectiveness. A hypothesis that is further substantiated by the recently published data of Mujika et al., that demonstrates a link between subjective sleep quality and the effectiveness of altitude training to increase total hemo-globin mass.
Specifically within female athletes, another potential crucial factor in the effectiveness of altitude training is the hypothalamic-pituitary-ovarian (HPO) axis function. The hypothalamic-pituitary-ovarian (HPO) axis regulates reproductive function, including the orchestration of ovula-tion and menstrual cyclicity. HPO axis suppression leads to altered hormonal patterns and conse-quently short luteal phases, anovulation and amenorrhoea. Shaw et al. concluded in their sys-tematic review that, if lowlanders travel to highland for short or longer duration, the high altitude-hypoxia affects their menstrual cycle more adversely than the natives. The variation in female hormones may contribute in unsuccessful ovulation, menstrual cycle, and subsequently pregnancy at high altitude. A disturbed HPO axis function at altitude can, subsequently, negatively im-pact the effectiveness of altitude training. For example, Heikura et al. recently reported lower pre-hypoxic exposure hemoglobin mass levels in amenorrheic versus eumenorrheic women, sug-gesting that menstrual dysfunction, an indicator of long-term low energy availability, may influence the altitude exposure-related increase in hemoglobin mass or its magnitude.
Therefore, the present study aims to evaluate the role of the impact of altitude on sleep and the menstrual cycle in the inter- and intraindividual variability of altitude training effectiveness. In order to do so, elite female cyclists will be monitored before, during and after an altitude training camp. The monitoring will include menstrual cycle characteristics, sleep and altitude effectiveness and will start three months before the start of the altitude training camp and end two months after the altitude training camp. Both naturally cycling women and women using contraceptives will be included in the study. Menstrual cycle monitoring will take place via self-reports and via a daily saliva (Eli Health) and urine (Proov) test to measure progesterone concentration. Besides proges-terone concentration, the sampled urine will also be used to perform an ovulation test on (i.e., measuring the luteinizing hormone). In addition, a blood sample will be collected at the start of each menstrual cycle to evaluate the concentration of menstrual cycle-related hormones (e.g., follicle-stimulating hormone, luteinizing hormone, estrogen, and progesterone) and to evaluate the functioning of the Hypothalamic-Pituitary-Adrenal Axis (i.e., cortisol concentration). Sleep monitoring will be performed via the use of questionnaires, actigraphy and polysomnography. Lastly, altitude effectiveness will be evaluated via the altitude-associated response in total hemoglobin mass and via an all out cycle ergometer task.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Elite female cyclists
Elite female cyclists participating in an altitude training camp
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Female
* Elite cyclist
Exclusion Criteria
18 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Royal Military Academy
UNKNOWN
Vrije Universiteit Brussel
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Bart Roelands
Professor
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Heikura IA, Burke LM, Bergland D, Uusitalo ALT, Mero AA, Stellingwerff T. Impact of Energy Availability, Health, and Sex on Hemoglobin-Mass Responses Following Live-High-Train-High Altitude Training in Elite Female and Male Distance Athletes. Int J Sports Physiol Perform. 2018 Sep 1;13(8):1090-1096. doi: 10.1123/ijspp.2017-0547. Epub 2018 Sep 13.
Shaw S, Ghosh D, Kumar U, Panjwani U, Kumar B. Impact of high altitude on key determinants of female reproductive health: a review. Int J Biometeorol. 2018 Nov;62(11):2045-2055. doi: 10.1007/s00484-018-1609-0. Epub 2018 Sep 14.
Burtscher J, Raberin A, Brocherie F, Malatesta D, Manferdelli G, Citherlet T, Krumm B, Bourdillon N, Antero J, Rasica L, Burtscher M, Millet GP. Recommendations for Women in Mountain Sports and Hypoxia Training/Conditioning. Sports Med. 2024 Apr;54(4):795-811. doi: 10.1007/s40279-023-01970-6. Epub 2023 Dec 12.
Mujika I, Tian R, Zelenkova I, Pyne DB. Highly Variable Hemoglobin-Mass Changes During Successive Altitude Training Camps in World-Class Female Water Polo Players. Int J Sports Physiol Perform. 2025 Oct 28;20(12):1763-1767. doi: 10.1123/ijspp.2025-0270. Print 2025 Dec 1.
Hoshikawa M, Uchida S, Sugo T, Kumai Y, Hanai Y, Kawahara T. Changes in sleep quality of athletes under normobaric hypoxia equivalent to 2,000-m altitude: a polysomnographic study. J Appl Physiol (1985). 2007 Dec;103(6):2005-11. doi: 10.1152/japplphysiol.00315.2007. Epub 2007 Aug 9.
West, J.B., et al., Sleep, in High altitude medicine and physiology, J.B.S. West, Robert B, A.M. Luks, and J.S. Milledge, Editors. 2013, CRC Press: Padstow, Cornwall.
McLean BD, Buttifant D, Gore CJ, White K, Liess C, Kemp J. Physiological and performance responses to a preseason altitude-training camp in elite team-sport athletes. Int J Sports Physiol Perform. 2013 Jul;8(4):391-9. doi: 10.1123/ijspp.8.4.391. Epub 2012 Nov 19.
McLean BD, Buttifant D, Gore CJ, White K, Kemp J. Year-to-year variability in haemoglobin mass response to two altitude training camps. Br J Sports Med. 2013 Dec;47 Suppl 1(Suppl 1):i51-8. doi: 10.1136/bjsports-2013-092744.
Hauser A, Troesch S, Saugy JJ, Schmitt L, Cejuela-Anta R, Faiss R, Steiner T, Robinson N, Millet GP, Wehrlin JP. Individual hemoglobin mass response to normobaric and hypobaric "live high-train low": A one-year crossover study. J Appl Physiol (1985). 2017 Aug 1;123(2):387-393. doi: 10.1152/japplphysiol.00932.2016. Epub 2017 May 18.
Friedmann B, Frese F, Menold E, Kauper F, Jost J, Bartsch P. Individual variation in the erythropoietic response to altitude training in elite junior swimmers. Br J Sports Med. 2005 Mar;39(3):148-53. doi: 10.1136/bjsm.2003.011387.
Chapman RF, Stray-Gundersen J, Levine BD. Individual variation in response to altitude training. J Appl Physiol (1985). 1998 Oct;85(4):1448-56. doi: 10.1152/jappl.1998.85.4.1448.
Millet GP, Chapman RF, Girard O, Brocherie F. Is live high-train low altitude training relevant for elite athletes? Flawed analysis from inaccurate data. Br J Sports Med. 2019 Aug;53(15):923-925. doi: 10.1136/bjsports-2017-098083. Epub 2017 Dec 15. No abstract available.
Racinais S, Periard JD, Piscione J, Bourdon PC, Cocking S, Ihsan M, Lacome M, Nichols D, Townsend N, Travers G, Wilson MG, Girard O. Intensified Training Supersedes the Impact of Heat and/or Altitude for Increasing Performance in Elite Rugby Union Players. Int J Sports Physiol Perform. 2021 Mar 5;16(10):1416-1423. doi: 10.1123/ijspp.2020-0630. Epub 2021 Mar 5.
Bejder J, Andersen AB, Buchardt R, Larsson TH, Olsen NV, Nordsborg NB. Endurance, aerobic high-intensity, and repeated sprint cycling performance is unaffected by normobaric "Live High-Train Low": a double-blind placebo-controlled cross-over study. Eur J Appl Physiol. 2017 May;117(5):979-988. doi: 10.1007/s00421-017-3586-0. Epub 2017 Mar 22.
Robach P, Hansen J, Pichon A, Meinild Lundby AK, Dandanell S, Slettalokken Falch G, Hammarstrom D, Pesta DH, Siebenmann C, Keiser S, Kerivel P, Whist JE, Ronnestad BR, Lundby C. Hypobaric live high-train low does not improve aerobic performance more than live low-train low in cross-country skiers. Scand J Med Sci Sports. 2018 Jun;28(6):1636-1652. doi: 10.1111/sms.13075. Epub 2018 Mar 22.
Bejder J, Nordsborg NB. Specificity of "Live High-Train Low" Altitude Training on Exercise Performance. Exerc Sport Sci Rev. 2018 Apr;46(2):129-136. doi: 10.1249/JES.0000000000000144.
Lundby C, Robach P. Does 'altitude training' increase exercise performance in elite athletes? Exp Physiol. 2016 Jul 1;101(7):783-8. doi: 10.1113/EP085579. Epub 2016 Jun 13.
Lundby C, Millet GP, Calbet JA, Bartsch P, Subudhi AW. Does 'altitude training' increase exercise performance in elite athletes? Br J Sports Med. 2012 Sep;46(11):792-5. doi: 10.1136/bjsports-2012-091231. Epub 2012 Jul 14.
Gore CJ, Sharpe K, Garvican-Lewis LA, Saunders PU, Humberstone CE, Robertson EY, Wachsmuth NB, Clark SA, McLean BD, Friedmann-Bette B, Neya M, Pottgiesser T, Schumacher YO, Schmidt WF. Altitude training and haemoglobin mass from the optimised carbon monoxide rebreathing method determined by a meta-analysis. Br J Sports Med. 2013 Dec;47 Suppl 1(Suppl 1):i31-9. doi: 10.1136/bjsports-2013-092840.
Wilber RL. Current trends in altitude training. Sports Med. 2001;31(4):249-65. doi: 10.2165/00007256-200131040-00002.
Mujika I, Sharma AP, Stellingwerff T. Contemporary Periodization of Altitude Training for Elite Endurance Athletes: A Narrative Review. Sports Med. 2019 Nov;49(11):1651-1669. doi: 10.1007/s40279-019-01165-y.
Bonetti DL, Hopkins WG. Sea-level exercise performance following adaptation to hypoxia: a meta-analysis. Sports Med. 2009;39(2):107-27. doi: 10.2165/00007256-200939020-00002.
Billaut F, Gore CJ, Aughey RJ. Enhancing team-sport athlete performance: is altitude training relevant? Sports Med. 2012 Sep 1;42(9):751-67. doi: 10.1007/BF03262293.
Girard O, Amann M, Aughey R, Billaut F, Bishop DJ, Bourdon P, Buchheit M, Chapman R, D'Hooghe M, Garvican-Lewis LA, Gore CJ, Millet GP, Roach GD, Sargent C, Saunders PU, Schmidt W, Schumacher YO. Position statement--altitude training for improving team-sport players' performance: current knowledge and unresolved issues. Br J Sports Med. 2013 Dec;47 Suppl 1(Suppl 1):i8-16. doi: 10.1136/bjsports-2013-093109.
Nummela A, Eronen T, Koponen A, Tikkanen H, Peltonen JE. Variability in hemoglobin mass response to altitude training camps. Scand J Med Sci Sports. 2021 Jan;31(1):44-51. doi: 10.1111/sms.13804. Epub 2020 Sep 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FEMHEALTH
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.