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Completed

NCT Number: NCT03616652

Non-deceptive Application of Placebos in Insomnia

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.

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Key information

Conditions

Insomnia Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Marburg, 35032, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

Placebo pill

Film sequence

Other

The experimental group watches a film about the power of placebo effects.

Primary outcomes

  1. Self-reported Total Sleep Time

    Time frame: change from baseline to 1 night after placebo intake

    assessed by sleep diary

Secondary outcomes

  1. Objective Sleep Efficiency

    Time frame: change from baseline to 1 night after placebo intake

    assessed by actigraphy

  2. Objective Total Sleep Time

    Time frame: change from baseline to 1 night after placebo intake

    assessed by actigraphy

  3. Objective Total Sleep Time

    Time frame: change from baseline to 1 night after placebo intake

    assessed by polysomnography

  4. Objective Sleep Onset Latency

    Time frame: change from baseline to 1 night after placebo intake

    assessed by polysomnography

  5. Self-reported Sleep Onset Latency

    Time frame: change from baseline to 1 night after placebo intake

    assessed by sleep diary

Sponsors and collaborators

Lead sponsor

Philipps University Marburg

Other

Registry information

Acronym: NAP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2018
Registry last updated
Apr 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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