InsomniaNAPNCT03616652
Non-deceptive Application of Placebos in Insomnia
A study testing Film sequence in people with Insomnia, run by Philipps University Marburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Insomnia
- What is being tested?
- Film sequence
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2018to 31 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Clinical Psychology and Psychotherapy, Philipps-University Marburg
Marburg, 35032
About this study
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.
- Conditions
- Insomnia
- Being tested
- Placebo, Film sequence
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Placebo pill
Film sequenceOther
The experimental group watches a film about the power of placebo effects.
Film sequenceOther
The control group watches a film about sleep.
| Study group | Role | What they receive |
|---|---|---|
| Non-deceptive placebo group (additional information) | Experimental | 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. Receives: Drug: Placebo; Other: Film sequence |
| Non-deceptive placebo group (no additional information) | Placebo comparator | 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. Receives: Drug: Placebo; Other: Film sequence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported Total Sleep Time
assessed by sleep diary
Measured: change from baseline to 1 night after placebo intake
Secondary outcomes (5)
Objective Sleep Efficiency
assessed by actigraphy
Measured: change from baseline to 1 night after placebo intake
Objective Total Sleep Time
assessed by actigraphy
Measured: change from baseline to 1 night after placebo intake
Objective Total Sleep Time
assessed by polysomnography
Measured: change from baseline to 1 night after placebo intake
Objective Sleep Onset Latency
assessed by polysomnography
Measured: change from baseline to 1 night after placebo intake
Self-reported Sleep Onset Latency
assessed by sleep diary
Measured: change from baseline to 1 night after placebo intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2018
- Study start1 Oct 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philipps University Marburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Winfried Rief, Philipps University Marburg
- Investigators
- Winfried Rief, Prof. Dr., Principal investigator, Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03616652
- Sponsor's protocol ID
- 2017-43k
- Acronym
- NAP
- Status last verified
- Apr 2021
- First submitted
- 20 Jul 2018
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-deceptive Application of Placebos in Insomnia
- ClinicalTrials.gov ID
- NCT03616652
- Acronym / sponsor ID
- NAP / 2017-43k
- Conditions
- Insomnia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Philipps University MarburgUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 6 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-deceptive placebo group (additional information) | Experimental | Drug: Placebo, Other: Film sequenceParticipants 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. |
| Non-deceptive placebo group (no additional information) | Placebo comparator | Drug: Placebo, Other: Film sequenceParticipants 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. |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboPlacebo pill | Drug | Non-deceptive placebo group (additional information), Non-deceptive placebo group (no additional information) |
| Film sequenceThe experimental group watches a film about the power of placebo effects. | Other | Non-deceptive placebo group (additional information) |
| Film sequenceThe control group watches a film about sleep. | Other | Non-deceptive placebo group (no additional information) |
Primary outcome
Self-reported Total Sleep Time
Time frame: change from baseline to 1 night after placebo intake
assessed by sleep diary
5 secondary outcomes
Objective Sleep Efficiency
Time frame: change from baseline to 1 night after placebo intake
Objective Total Sleep Time
Time frame: change from baseline to 1 night after placebo intake
Objective Total Sleep Time
Time frame: change from baseline to 1 night after placebo intake
Objective Sleep Onset Latency
Time frame: change from baseline to 1 night after placebo intake
Self-reported Sleep Onset Latency
Time frame: change from baseline to 1 night after placebo intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Winfried Rief, Prof. Dr. principal investigator
Clinical Psychology and Psychotherapy, Department of Psychology, Philipps University Marburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Film sequence in people with Insomnia, run by Philipps University Marburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported Total Sleep Time (time frame: change from baseline to 1 night after placebo intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2021; AzTrials last refreshed its copy on 6 Nov 2026.