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Non-deceptive Application of Placebos in Insomnia (NAP)

Primary Purpose

Insomnia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Placebo
Film sequence
Film sequence
Sponsored by
Philipps University Marburg Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insomnia

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Non-deceptive placebo group (additional information)

Non-deceptive placebo group (no additional information)

Arm Description

Participants receive a placebo pill and are told that it is placebo. They receive additional information about the power of placebo effects via a film sequence before they take the placebo.

Participants receive a placebo pill and are told that it is placebo. They do not receive additional information about placebo effects. Instead, they watch a neutral film sequence about sleep.

Outcomes

Primary Outcome Measures

Self-reported Total Sleep Time
assessed by sleep diary

Secondary Outcome Measures

Objective Sleep Efficiency
assessed by actigraphy
Objective Total Sleep Time
assessed by actigraphy
Objective Total Sleep Time
assessed by polysomnography
Objective Sleep Onset Latency
assessed by polysomnography
Self-reported Sleep Onset Latency
assessed by sleep diary

Full Information

First Posted
July 20, 2018
Last Updated
April 12, 2021
Sponsor
Philipps University Marburg Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03616652
Brief Title
Non-deceptive Application of Placebos in Insomnia
Acronym
NAP
Official Title
Non-deceptive Application of Placebos in Insomnia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Philipps University Marburg Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-deceptive placebo group (additional information)
Arm Type
Experimental
Arm Description
Participants receive a placebo pill and are told that it is placebo. They receive additional information about the power of placebo effects via a film sequence before they take the placebo.
Arm Title
Non-deceptive placebo group (no additional information)
Arm Type
Placebo Comparator
Arm Description
Participants receive a placebo pill and are told that it is placebo. They do not receive additional information about placebo effects. Instead, they watch a neutral film sequence about sleep.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo pill
Intervention Type
Other
Intervention Name(s)
Film sequence
Intervention Description
The experimental group watches a film about the power of placebo effects.
Intervention Type
Other
Intervention Name(s)
Film sequence
Intervention Description
The control group watches a film about sleep.
Primary Outcome Measure Information:
Title
Self-reported Total Sleep Time
Description
assessed by sleep diary
Time Frame
change from baseline to 1 night after placebo intake
Secondary Outcome Measure Information:
Title
Objective Sleep Efficiency
Description
assessed by actigraphy
Time Frame
change from baseline to 1 night after placebo intake
Title
Objective Total Sleep Time
Description
assessed by actigraphy
Time Frame
change from baseline to 1 night after placebo intake
Title
Objective Total Sleep Time
Description
assessed by polysomnography
Time Frame
change from baseline to 1 night after placebo intake
Title
Objective Sleep Onset Latency
Description
assessed by polysomnography
Time Frame
change from baseline to 1 night after placebo intake
Title
Self-reported Sleep Onset Latency
Description
assessed by sleep diary
Time Frame
change from baseline to 1 night after placebo intake

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Winfried Rief, Prof. Dr.
Organizational Affiliation
Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
City
Marburg
ZIP/Postal Code
35032
Country
Germany

12. IPD Sharing Statement

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Non-deceptive Application of Placebos in Insomnia

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