Altitude Training Effectiveness; Is There a Role for Sleep and Menstrual Health?

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorVrije Universiteit Brussel

About this trial

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., fol-licle-stimulating hormone, luteinizing hormone, estrogen, and progesterone) and to evaluate the functioning of the Hypothalamic-Pituitary-Adrenal Axis (i.e., cortisol concentration). Sleep moni-toring 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Healthy

Female

Elite cyclist

Disqualifiers

None

Trial population

Eligibility criteria are being a healthy female elite cyclist. Both naturally cycling women and women who use contraception are eligible.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: Elite female cyclists

Trial outcomes

Primary outcomes

1

Total hemoglobin mass (tHBmass)

An optimized carbon monoxide rebreathing method will be used. The carbon monoxide dose will be 0.8 mL/kg body mass. The rebreathing procedure will be performed for 2 minutes, in a seated position, through a glass spirometer.

Time frame
Will be measured at sea level 5 days before (i.e., Day -5) and on the last day of the altitude training camp (i.e., Day 18)
2

A standardized 5-min all-out cycling test

After a 10-15 min warm-up, participants will complete a maximal 5-min effort in linear (cadence-dependent) mode, during which they will be instructed to produce the highest sustainable power for the entire duration. Power output, cadence, and heart rate will be recorded continuously. Mean 5-min power (W and W·kg-¹) will serve as the primary performance outcome, with peak power and end-segment power examined as secondary metrics.

Time frame
Will be performed on a calibrated cycle ergometer 5 days before (i.e. Day -5) and on the final day of the altitude training camp (i.e., Day 18)
3

A wake and sleep diary

Will be used regarding sleep (completed by participants the morning upon waking) and daytime activity (completed prior to their bedtime). The participants have to indicate, on a 24-h scale with a time resolution of 15 min, 1) when they started trying to fall asleep, 2) when they actually fell asleep, 3) whether they woke up after falling asleep and, if yes, for how long, 4) when they woke up, and 5) whether they took a nap out of bed and, if yes, for how long. Subsequently, the following outcome measures will be calculated: total time spent in bed, sleep onset latency, wake after sleep onset, total sleep time, total nap time, bed-time and risetime. In addition, participants will also be asked to rate their sleep quality, quality of the wake-up and shape of the day (score on a 10-point scale).

Time frame
Participants will have to fill out this wake and sleep diary daily from Day -7 to Day 25 (Day 0 being the first day of the altitude training camp).
4

The Pittsburgh Sleep Quality Index (PSQI)

The PSQI includes 19 self-assessment items that combine to give 7 components of the overall score, with each component receiving a score of 0 to 3. A score of 0 indicates no difficulty, while a score of 3 indicates severe difficulty. The 7 components of the score add up to give an overall score ranging from 0 to 21 points, with 0 indicating no difficulty and 21 indicating major difficul-ties. An overall sum of 5 or more indicates a 'bad' sleeper.

Time frame
The PSQI will have to be completed at the end of each month in which the menstrual cyclus is monitored (i.e., Month -3 final day, Month -2 final day, Month -1 final day, Month 0 final day, Month 1 final day and Month 2 final day).

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vrije Universiteit Brussel

Lead sponsor

Royal Military Academy

Collaborator

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