Insomnia
Conditions
Brief summary
The purpose of this study is to evaluate whether non-deceptive application of a placebo has an impact on subjective or objective sleep parameters in patients with primary insomnia.
Interventions
DRUGPlacebo
Placebo pill
OTHERFilm sequence
The experimental group watches a film about the power of placebo effects.
Sponsors
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
* age between 18 years to 69 years * fluent in German language * provide written informed consent * ability to understand the explanations and instructions given by the study physician and the investigator
Exclusion criteria
* evidence for sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia) * allergies to ingredients of placebo * patients scoring below 8 or above 21 on the Insomnia Severity Index * patients suffering from a mental disorder as verified by the SCID * patients suffering from an acute physical illness * nicotine consumption \> 10 cigarettes/day * unwillingness to refrain from alcohol consumption throughout the study * change in concomitant medication regime during the last 2 weeks prior to visit 1 or after randomization * intake of psychotropic drugs during the last 3 months prior to visit 1 * currently pregnant (verified by urine pregnancy test) or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported Total Sleep Time | change from baseline to 1 night after placebo intake | assessed by sleep diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Sleep Efficiency | change from baseline to 1 night after placebo intake | assessed by actigraphy |
| Objective Total Sleep Time | change from baseline to 1 night after placebo intake | assessed by actigraphy |
| Objective Sleep Onset Latency | change from baseline to 1 night after placebo intake | assessed by polysomnography |
| Self-reported Sleep Onset Latency | change from baseline to 1 night after placebo intake | assessed by sleep diary |
Countries
Germany
Outcome results
None listed