Treating jet-lag and improving sleep in healthy lowlanders flying across several time zones and ascending to high altitude Other
Conditions
Interventions
The RESET intervention consists of five components
each will be optimally timed to promote rapid resetting of body clocks to the new time zone. These components include restrictions on timing of (1) exposure to light, (2) food consumption, (3) physica
Sponsors
University of Edinburgh
NHS Lothian
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Accepted as members of the APEX 6 expedition (aged 18-25 years; there is no obligation to take part in the research having been accepted on the expedition). 2. Able to provide details of registration at a GP surgery. 3. In the case of volunteers who regularly attend a medical clinic, confirmation that they have informed the hospital specialist that they intend to participate in the expedition. 4. Identify themselves as being healthy. 5. Capacity to understand written and verbal information provided in English, and able to provide valid written informed consent to participate.
Exclusion criteria
Exclusion criteria: 1. Previous admission to hospital with acute asthma 2. Significant cardio-respiratory disease 3. Regular cardiovascular medications 4. Advised against travel to altitude by GP, relevant hospital specialist, or APEX6 expedition doctors 5. Positive COVID-19 test within 14 days prior to departure 6. COVID-19 symptoms within 14 days prior to departure, without negative COVID-19 test 7. Pregnancy/possible pregnancy 8. Smoking The following ‘absolute research’ exclusion criteria will prevent participants taking part in all research elements on the APEX 6 expedition (including the RESET trial), but will not prevent them from joining the APEX 6 expedition: 9. Subjects who have been exposed to altitude above 2500m in the two months preceding the expedition. 10. Subjects who take acetazolamide (Diamox) during the expedition 11. Subjects who consume alcohol or South American herbal-based remedies for AMS (coca-leaf tea/mate de coca) on research sampling days The following ‘specific’ exclusion criteria will prevent participants taking part in the observational ‘Hypoxia and body clocks’ research element of APEX 6 and the RESET trial, but will not prevent them from taking part in other research elements on APEX 6: 12. Subjects who carry out night shift work in the week before the expedition, have a clinically diagnosed sleep disorder, or who do not fly to South America from Europe and back again for the expedition. The following ‘specific’ exclusion criteria relate only to the RESET trial: 13. Subjects with a history of gastric ulceration, diabetes mellitus, or that take systemic steroid-based medications in the month before the expedition will be excluded from the trial in its entirety. 14. Any subject with a body weight of <80 pounds, gastrointestinal disease, history of glaucoma, gastric cancer, previous gastrointestinal surgery/obstruction, epilepsy, liver disease, heart disease, renal disease, signs/history of impaired gag reflex, previous adverse reaction to either dexamethasone or omeprazole, current infection or pre-existing immunocompromise will be excluded from the pharmaceutical aspect of the intervention and the CorTemp™ element of the trial. 15. Participants that require any prescription or non-prescription medications (with the exception of paracetamol, hormone-based contraceptives, fluoxetine, sertraline, trazodone, codeine and gabapentin; updated 07/05/2022: antihistamines, tetracycline antibiotics, isotretinoin, vitamin or mineral supplements, locally administered steroids [including topical creams, inhalers, and nasal sprays]) during their allocated 3-day intervention period will be excluded from the medicinal aspect of the intervention only (dexamethasone and omeprazole). 16. Any subject with a body weight of <80 pounds, gastrointestinal disease, history of gastric cancer, previous gastrointestinal surgery/obstruction, signs/history of impaired gag reflex, will be excluded from the CorTemp™ component only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean daily rate (min/day) of circadian phase (body clock) re-adjustment between the intervention and non-intervention arms over the first 5 days in the new destination. ActTrust2 device readouts for sleep and local light exposure will enable determination of the phase angle for each participant on each day of data collection (the phase angle establishes the relationship between a participant’s body clock timing and that of the external light/dark cues – thus providing a measure of entrainment). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Chronotype measured using the Munich Chronotype Questionnaire (MCQ) and continuous monitoring of activity and light exposure by wrist-worn actigraphy. The MCQ will be conducted once, 8-10 days prior to the expedition. Actigraphy data will be collected for one week prior to the expedition, throughout the data collection period at high altitude, and from the day of return departure to the UK until 7 days after arrival in the UK. 2. Sleep quality measured using characteristics derived from actigraphy and Pittsburgh Sleep Quality Index (PSQI). Actigraphy data will be collected as described above. The PSQI score will be obtained 8-10 days prior to the expedition and one week after returning to the UK. 3. Circadian function using the circadian function index (CFI) derived from actigraphy data, collected as described above. 4. Total Acute Mountain Sickness (AMS) score by combining the results of Visual Analogue Scale (VAS) sheets (completed pre- and post-expedition and up to four times per day during the data collection period at high altitude), and the 2018 Lake Louise AMS Score questionnaire (completed pre- and post-expedition, and once per day during the data collection period at high altitude). 5. Mood using the questionnaire-based Brunel Mood Scale (BMS), completed at pre- and post-expedition testing, and once per day during the data collection period at high altitude. 6. Cognitive function using the computer-based Psychomotor Vigilance Task (PVT) performed at pre- and post-expedition testing, and once per day during the data collection period at high altitude. 7. Genetic variation according to expression quantitative trait loci (eQTL) obtained using genomic DNA extracted from venous blood collected at baseline pre-expedition testing. | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactAlastair Woodhead
Outcome results
None listed