Ignite Creation Date:
2024-05-06 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06225817
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-01-16
Brief Title:
Placebo Impacts Sleep and Pain Modulation in Chronic Headache
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
The Impact of Open-label Placebo on Sleep and Pain Modulation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this free-choice parallel design clinical trial is to examine the potential beneficial effects of using open-label placebo OLP in improving chronic headache related outcomes and sleep quality This study will enroll a cohort of participants with chronic headache which lasts for more than 3 months The main questions it aims to answer are
1 Will participants with chronic headache be more likely to take open-label placebo pills if they are introduced to the effects of placebo
2 Will taking open-label placebo improve chronic pain related outcomes such as chronic pain intensity interference levels of anxiety and depression in the cohort of chronic headache
3 Will open-label placebo improve sleep quality in participants suffering from chronic headache
To answer the above questions participants with chronic headache will be randomly assigned to two groups 1 Open-label placebo group where participants will be asked to take open-label placebo pills one pill per day for a total of 45 days 2 wait-list group where participants will maintain their usual care without introducing open-label placebo to them during the 45 days monitoring Researchers will compare the chronic pain intensity interference mood anxiety and sleep quality between the open-label placebo group and the wait-list group Daily chronic pain will be measured using visual analog scale VAS ranging from 0no pain at all to 100maximum tolerable pain Chronic pain interference using Patient-Reported Outcomes Measurement Information System PROMIS pain interference and pain behavior Anxiety and depression will be measured using PROMIS-anxiety and PROMIS-depression scales respectively Finally sleep quality will be quantified using the objective measurement Motion Watch during the 45 days intervention and monitoring In order to have a rigorous measurement of the baseline pain and sleep fluctuation this study will include a 7-day phenotyping period before the starting of the 45-day intervention and monitoring During the 7-day phenotyping period participants will record their daily chronic pain and sleep quality using polysomnography
1 Will participants with chronic headache be more likely to take open-label placebo pills if they are introduced to the effects of placebo
2 Will taking open-label placebo improve chronic pain related outcomes such as chronic pain intensity interference levels of anxiety and depression in the cohort of chronic headache
3 Will open-label placebo improve sleep quality in participants suffering from chronic headache
To answer the above questions participants with chronic headache will be randomly assigned to two groups 1 Open-label placebo group where participants will be asked to take open-label placebo pills one pill per day for a total of 45 days 2 wait-list group where participants will maintain their usual care without introducing open-label placebo to them during the 45 days monitoring Researchers will compare the chronic pain intensity interference mood anxiety and sleep quality between the open-label placebo group and the wait-list group Daily chronic pain will be measured using visual analog scale VAS ranging from 0no pain at all to 100maximum tolerable pain Chronic pain interference using Patient-Reported Outcomes Measurement Information System PROMIS pain interference and pain behavior Anxiety and depression will be measured using PROMIS-anxiety and PROMIS-depression scales respectively Finally sleep quality will be quantified using the objective measurement Motion Watch during the 45 days intervention and monitoring In order to have a rigorous measurement of the baseline pain and sleep fluctuation this study will include a 7-day phenotyping period before the starting of the 45-day intervention and monitoring During the 7-day phenotyping period participants will record their daily chronic pain and sleep quality using polysomnography
Detailed Description:
This is a longitudinal parallel randomized clinical trial with chronic headache participants randomly assigned to either 1 the open-label placebo OLP group or 2 the wait-list group To examine how baseline chronic pain and sleep patterns could have impacted the effects of OLP we will deep-phenotype participants based on their sleep profiles and fluctuations in their chronic pain characteristics via a 7-day phenotyping phase Following the 7-day phenotyping phase participants will enter a 45-day intervention phase The nature of the participation will be voluntary Namely participants can withdraw during trial from the study without any consequences
Phenotyping phase 7-day The phenotyping phase includes an in-person visit and a 7-day at-home monitoring period During the in-person visit after signing the informed consent form with the trained staff participants will complete a heat pain sensitivity test using a 30mmx30mm Advanced Thermal Stimulator ATS via the Medoc Pathway system Medoc Advanced Medical Systems Medoc Ltd Israel Painful and non-painful stimuli will be delivered to the ventral forearm of the non-dominant hand
After the in-person visit participants will enter a 7-day daily monitoring period where their daily pain expectations pain experience fluctuations and sleep diaries will be assessed in real time and in their natural environment using the Ecological Momentary Assessment EMA method Sleep profiles will be assessed using polysomnography to obtain natural sleep architectures including the duration of different sleep stages sleep efficiency breathing and body movement during sleep
Free-choice OLP intervention Immediately following the phenotyping phase participants will return to the laboratory before entering the 45-day intervention phase Participants will be randomized to either the OLP group or the wait-list group Participants in the OLP group will receive a bottle of 45 OLP pills According to the free-choice paradigm participants in the OLP group are allowed to choose whether to take the pills each day during the intervention This paradigm maximizes participant benefit because it provides the option of not taking the placebo pills Participants in the wait-list group will not receive OLP pills until the end of the 45-day monitoring period
Phenotyping phase 7-day The phenotyping phase includes an in-person visit and a 7-day at-home monitoring period During the in-person visit after signing the informed consent form with the trained staff participants will complete a heat pain sensitivity test using a 30mmx30mm Advanced Thermal Stimulator ATS via the Medoc Pathway system Medoc Advanced Medical Systems Medoc Ltd Israel Painful and non-painful stimuli will be delivered to the ventral forearm of the non-dominant hand
After the in-person visit participants will enter a 7-day daily monitoring period where their daily pain expectations pain experience fluctuations and sleep diaries will be assessed in real time and in their natural environment using the Ecological Momentary Assessment EMA method Sleep profiles will be assessed using polysomnography to obtain natural sleep architectures including the duration of different sleep stages sleep efficiency breathing and body movement during sleep
Free-choice OLP intervention Immediately following the phenotyping phase participants will return to the laboratory before entering the 45-day intervention phase Participants will be randomized to either the OLP group or the wait-list group Participants in the OLP group will receive a bottle of 45 OLP pills According to the free-choice paradigm participants in the OLP group are allowed to choose whether to take the pills each day during the intervention This paradigm maximizes participant benefit because it provides the option of not taking the placebo pills Participants in the wait-list group will not receive OLP pills until the end of the 45-day monitoring period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None