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Ambulatory thermoregulatory system identification in relation to vigilance disturbances.

Ambulatory thermoregulatory system identification in relation to vigilance disturbances. - Sleep, fatigue and body temperature in health and disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON40230
Enrollment
150
Registered
2013-10-28
Start date
2014-08-05
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatigue sleep problems

Interventions

Eight of the non-active duty pilots will be requested to shorten their habitual sleep duration by 1 hour in the 4 nights preceding the lab measurements. Another eight non-active duty pilots will be

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Participants will only be included if they can be classified to one of the four most prevalent insomnia phenotypes, narcolepsy, vasovagal syncope or hypothalamic pituitary insufficiency. Participants have to be at least 18 years old and less than 70 years old. Active duty pilots will be included if they are currently employed by an airline, in possession of a valid Air Transport Pilots License (ATPL), valid medical clearance and a type rating. Non-active duty pilots possess a frozen ATPL (i.e. they completed their training, but don*t have the required 1500 hours of flying experience yet). All pilots will be between 20 and 58 years of age.

Exclusion criteria

Exclusion criteria: Participants will be excluded if they report an eye disease incompatible with light manipulation (ocular pathology or color deficiency). Comorbidity of other clinically diagnosed primary somatic or psychiatric disorders. Women that are pregnant or currently breast feeding. Current shift work, or shift work in the month before the study. Crossing several time zones in the month before the study. Shift work and travel will NOT be exclusion criteria for active duty pilots.

Design outcomes

Primary

MeasureTime frame
The study aims to identify disease-specific deviations in the multivariate thermoregulatory and vigilance response-parameter profile with possible value for diagnosis and for a better understanding of the involvement of thermoregulatory state in vigilance complaints. As such, rather than a single variable, the multivariate thermoregulatory and vigilance response-parameter profile is the main outcome measure. The multivariate profile will be reduced to significant variables with discriminative value to differentiate the vigilance (more-fatigued vs less-fatigued) and diagnostic profiles (i.e. different disorders) in laboratory and ambulatory recordings. The multivariate profile will consist of three descriptive outcomes (delay to response onset, sensitivity slope of the response and saturation level) for each of the physiological variables described above. The vigilance response profile will consist of objective vigilance (EEG and PVT) and subjective vigilance, fatigue, sleepiness and effort. In addition, the participants will have a diagnostic profile based on their clinical diagnosis. The multi-parameter profile approach has a risk of including parameters that differ between groups by mere chance. Therefore, using the leave-one-out cross-validation approach, the optimally discriminating multivariate profile for any specific diagnostic group will be determined for 29 patients each time and evaluated for the remaining one to obtain overall classification reliability.

Secondary

MeasureTime frame
* Circadian rhythms of skin temperature, activity and posture. * Sleep quality estimates derived from actigraphy. * Daily exposure to environmental temperature, humidity and light. * Daily average and variability of subjective feelings of thermal comfort, sensation, arousal, vigilance, stress and caffeine intake. * Descriptive statistics of the participants obtained through questionnaires on the website of the Netherlands Sleep Registry (www.slaapregister.nl), which includes medical history, history of or current sleep disorders, chronotype, sleep quality, level of sleepiness and fatigue.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)