Developing an effective method of determining circadian phase in humans for clinical applications

Developing an effective method of determining circadian phase in humans for clinical applications - Improving biological clock measurements

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42265

Enrollment

Registered

2014-09-09

Start date

2014-10-01

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

individuele variatie in 24-uurs ritmiek biological rhythm circadian clock

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: healthy men and women, aged 20-30 or 50-60 early/late/normal chronotype

Exclusion criteria

Exclusion criteria: Bad sleepers (PSQI >10) Depressive tendencies (BDI >8) (HADS >8) Anxiety problems (HADS >8) Chronotype of relatively late (20-30 year olds MSF 5.63-6.29-60 year olds MSF 4.5-5.08) or relatively early (20-30 year olds MSF 4.29-5.044, 50-60 year olds MSF 3.27-4.0) Chronic (psychiatric or somatic) disease Smokers Recreational drug use (e.g. cannabis, ectasy, GHB etc.) Past head injury or epileptic fits Medically diagnosed sleep disorders Eye complaints or eye surgery in the past (not including contact lenses or glasses) Use of chronic (photosensitizing) medication in 3 months prior to the start of the study Regular use of sleep medication or stimulating drugs Colour blindness More than 3 glasses of alcohol per day More than 8 caffeinated drinks per day Shiftwork in 3 months prior to the start of the study Travelled across more than 1 timezone in the month prior to the start of the study People with a BMI lower than 18 and higher than 27, or weighing below 36kg. Actual or suspected gastrointestinal obstructive disease Having a disorder or impairment of the gag reflex Previous gastrointestinal surgery Felinization of the oesophagus Hypo-motility disorders of the gastrointestinal tract Cardio pacemaker or any other implanted electro-medical device People who work with or plan to come in contact with Magnetic devices during the study (hospital or scientific grade only)

Design outcomes

Primary

Measure	Time frame
The primary study parameters are the model parameter-estimates of the daily profile of skin temperature, light exposure, core body temperature, activity, heart rate, sleep parameters (EEG and self-reported) and salivary melatonin profile for each participant. The outcome measures will be the different model parameter estimates required for late/early chronotypes, both sexes and the two age groups to best estimate the phase determined by the salivary melatonin sampling.	—

Measure

Time frame

The primary study parameters are the model parameter-estimates of the daily profile of skin temperature, light exposure, core body temperature, activity, heart rate, sleep parameters (EEG and self-reported) and salivary melatonin profile for each participant. The outcome measures will be the different model parameter estimates required for late/early chronotypes, both sexes and the two age groups to best estimate the phase determined by the salivary melatonin sampling.

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Secondary

Measure	Time frame
Differences between working days an free days will also be analysed, but this is not determinant for the size of the study population.	—

Countries

Netherlands

Outcome results