Non-deceptive Application of Placebos in Insomnia

Insomnia Clinical Trial

— NAP  

Official title:

Non-deceptive Application of Placebos in Insomnia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03616652
• Other study ID #: 2017-43k
• Status: Completed
• Phase: N/A
• Start date: October 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: April 2021
• Source: Philipps University Marburg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Insomnia
• Sleep Initiation and Maintenance Disorders

Intervention

Drug:
• Placebo
Placebo pill

Other:
• Film sequence
The experimental group watches a film about the power of placebo effects.
• Film sequence
The control group watches a film about sleep.

Locations

Country	Name	City	State
Germany	Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg	Marburg

Sponsors (1)

Lead Sponsor	Collaborator
Philipps University Marburg Medical Center

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported Total Sleep Time	assessed by sleep diary	change from baseline to 1 night after placebo intake
Secondary	Objective Sleep Efficiency	assessed by actigraphy	change from baseline to 1 night after placebo intake
Secondary	Objective Total Sleep Time	assessed by actigraphy	change from baseline to 1 night after placebo intake
Secondary	Objective Total Sleep Time	assessed by polysomnography	change from baseline to 1 night after placebo intake
Secondary	Objective Sleep Onset Latency	assessed by polysomnography	change from baseline to 1 night after placebo intake
Secondary	Self-reported Sleep Onset Latency	assessed by sleep diary	change from baseline to 1 night after placebo intake