Non-deceptive Application of Placebos in Insomnia

• Status: Completed
• Trial end date: 2020-01-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Philipps University Marburg Medical Center

Criteria

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