Insomnia Sleep problems
Conditions
Interventions
The intervention will comprise one sedentary period and two period of increased
physical activity with different daily patterns: 1) active morning
2) active
evening with a duration of 14 days each. In both active intervention arms,
participants will follow an exercise program containing outdoor physical
exercise sessions (Vitality Club) conta
a 1-hour training session of various moderate to vigorous
activities. The training sessions will be held either in the morning or evening
(depending on the intervention arm) and will be one hour lon
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Aged between 60 and 80 years old • Retired • Long lasting sleep problems (as assessed by a the screening questionnaire administered telephonically and by the ISI which will be filled out during the screening visit) • Access to and ability to use a smart phone (Android or Apple)
Exclusion criteria
Exclusion criteria: • Currently employed or working • Participation in any sort of fasting regimen (e.g. intermitted fasting or Ramadan) • Experienced recent (
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main outcome of this study will be insomnia severity which will be measured by the Dutch version of the ISI ranging from 0-28 (0-7: no clinically significant insomnia; 8-14: subthreshold insomnia; 15-21: moderate severity clinical insomnia; 22-28: severe clinical insomnia). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary and exploratory endpoints include: Biological clock function • Clockgene expression • Core body temperature (°C) o Diurnal pattern o Time of lowest temperature • Melatonin o Dim light melatonin onset (DLMO) Physiological parameters • Heart rate o Diurnal pattern o Average o Resting heart rate o Minimum/peak heart rate (5 and 95 percentile) • Heart rate variability (HRV) • Breathing rate • Oxygen saturation (SpO2) Mental health • Subjective mood o Diurnal pattern of: * Positive affectivity * Negative affectivity * Energy * Fatigue * Cognition • (objective) Electrodermal activity (emotional arousal and stress) Behavioural factors • Food intake o Frequency o Timing • Habitual sleep (Table 8.1) o Sleep latency (min) o Duration (min) o Efficiency (%) o Sleep phases (%, min) o Awakenings at night (x, min) o Rested feeling (subjective, 0-7) o General satisfaction with sleep (subjective, 0-7) Biochemistry • Glucose metabolism* • Inflammatory markers • Liver function • Kidney function • Thyroid function • White blood cell count | — |
Countries
Netherlands
Outcome results
None listed