Restless Legs SyndromeHDAX1NCT04303143
Hypnosis and Direct Autonomic Experience Influence on Chronic Symptoms
An observational study of Restless Legs Syndrome and Multiple Sclerosis, run by Inner Group Inc..
Trial summary
Study will look at a limited number of participants with various chronic symptoms. Investigating a new and novel form of hypnosis application called "Direct Autonomic Experience (DAX)" which is using combination of visualization, metaphor, post-hypnotic suggestion and anchoring. Read more about this study
- Who is it for?
- Ages 12 years and olderHealthy volunteers can take part
- Conditions the study is for
- Restless Legs Syndrome, Multiple Sclerosis, Trauma, Psychological
- What is being tested?
- Self-Hypnosis
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Jul 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 12 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Open to anyone over age or 12 (with proper adult/guardian supervision/authorization) with a proper medical chronic condition with one discomfort item (may have many, but only picking one) to be measured and evaluated over term of this study
Who may be able to join
- Participant must have a proper medical diagnosis of chronic condition.
- Existing medical treatments are having little to no effect on a discomfort metric to measure
- SUDS to be evaluated could be physical or emotional in nature (e.g. Anxiety level, or Leg Cramping/moving)
- Must be motivated and willing to participate in a study that uses hypnosis, placebo and/or nocebo type mental matters.
- Participant must continue existing medical treatments (as recommended/adjusted by such outside professionals) and continue to see and be monitored by new/existing medical professionals during the term of study.
- Must have technology of computers/internet/support to be able to attend regular video chat/conferences for needed interactions with study.
- Must have schedule availability and flexibility to meet in video chats/conferences as required.
- Must have the computer skills/resources and aptitude to handle video chat/conference and able to have resources/friends/knowledge that can help if technical issues arise to allow conference to occur (can handle restarting a video conference if crashes or network acts up)
Who cannot join
- Acute and short term discomfort matters not being measured that outside scope of chronic condition.
- Must not be active in any other studies or such studies deemed to not interact with this.
- Does not have a properly diagnosed chronic condition (exception are control subjects)
Trial locations and contacts
No sites are listed yet.
About this study
Study will look at a limited number of participants with various chronic symptoms. Investigating a new and novel form of hypnosis application called "Direct Autonomic Experience (DAX)" which is using combination of visualization, metaphor, post-hypnotic suggestion and anchoring.
Purpose is to confirm that DAX generally appears to impact SUDS value and subjects report observed level of effect on short and longer term measurements.
Most significantly, testing that DAX technique/action is reusable later if the measured SUDS value returns or increases.
Read the detailed description
Hypnosis and Direct Autonomic Experience Influence on Chronic Symptoms One common characteristic of many chronic conditions is the neurology/ biology/ symptomology may change slightly or signficantly over time. So an initial process/plan that worked well for affecting a SUDS discomfort level, may no longer work or work as well.
DAX is designed to be adaptive such that as matters that affected the initial SUDS conditions may have changed, shifted, grown or otherwise be different.
(Examples are increased lesions with MS). Where initial patterns were created with a certain set of neural condition and pathways. But now days/weeks later, with new pathways created, can a previously installed DAX pattern adjust and shift to accommodate the new neural patterns based on participants willingness and self-instruction, or does it require professional adjustment.
Example participant given strong post-hypnotic suggestions/anchor/etc to squeeze right hand in certain way to bring relief to leg discomfort. Initial testing shows working. Now time has shifted, maybe new pathways or other chronic conditions have changed. Can the DAX processes the participant has been taught handle these changes or does it require a professional to re-apply/boost or incorporate new details to get significant changes to reported SUDS discomfort values.
- Conditions
- Restless Legs Syndrome, Multiple Sclerosis, Trauma, Psychological, Chronic Disease, Trauma
- Being tested
- Self-Hypnosis, Direct Autonomic Experience Control
- Keywords
- hypnosis, trauma, chronic disease
- Medical subject headings
- Restless Legs Syndrome, Multiple Sclerosis, Psychological Trauma, Chronic Disease, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-HypnosisBehavioural
Self-Hypnosis
Direct Autonomic Experience ControlBehavioural
Also called DAX Control
Direct Autonomic Experience Control. Use of learned mental tool/process to affect outcome measure of SUDS discomfort experience. (eg. Squeeze hand as pre-learned mental anchor to relieve discomfort in lower legs)
| Study group | Role | What they receive |
|---|---|---|
| Primary | Primary Receives: Behavioral: Self-Hypnosis; Behavioral: Direct Autonomic Experience Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
SUDS
Subject Unit of Discomfort Symptom. Each patient will have different types and levels of discomfort. Could be back, legs, whatever. Once identified and a numerical value applied to level of discomfort on scale of 1 to 10. We will track that particular SUDS metric through the study, looking for various factors that enable the measured value to drop to lowest value and to re-correct back to lower value if conditions cause it to rise again.
Measured: 7 days
Secondary outcomes (2)
DAX Control of SUDS Change
Direct Autonomic Experience (DAX) is patients ability to use pre-learned applied conscious and subconscious controls to their specified Subject Unit of Discomfort Symptom (SUDS) Discomfort related to their chronic condition. (self-adjustment). Comparing what patient can do on own, compared to when professional doing same to impact the identified SUDS discomfort item.
Measured: 1 day
Professional Control of SUDS change
Participants ability to use pre-learned applied conscious and subconscious controls to their specified Subject Unit of Discomfort Symptom (SUDS) Discomfort related to their chronic condition with professional assistance (professional-adjustment)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study startMar 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionJul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Restless Legs SyndromeStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Inner Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Martin Vendemia, BCH, MNLP, Principal investigator, Inner Group Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303143
- Sponsor's protocol ID
- HypDax1
- Acronym
- HDAX1
- Status last verified
- Jul 2020
- First submitted
- 7 Mar 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis and Direct Autonomic Experience Influence on Chronic Symptoms
- ClinicalTrials.gov ID
- NCT04303143
- Acronym / sponsor ID
- HDAX1 / HypDax1
- Conditions
- Restless Legs Syndrome, Multiple Sclerosis, Trauma, Psychological, Chronic Disease, Trauma
- Keywords
- hypnosis, trauma, chronic disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Inner Group Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- Jul 2021 (estimated)
- First posted
- 10 Mar 2020 (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.
Study will look at a limited number of participants with various chronic symptoms. Investigating a new and novel form of hypnosis application called "Direct Autonomic Experience (DAX)" which is using combination of visualization, metaphor, post-hypnotic suggestion and anchoring.
Purpose is to confirm that DAX generally appears to impact SUDS value and subjects report observed level of effect on short and longer term measurements.
Most significantly, testing that DAX technique/action is reusable later if the measured SUDS value returns or increases.
Detailed description
Hypnosis and Direct Autonomic Experience Influence on Chronic Symptoms One common characteristic of many chronic conditions is the neurology/ biology/ symptomology may change slightly or signficantly over time. So an initial process/plan that worked well for affecting a SUDS discomfort level, may no longer work or work as well.
DAX is designed to be adaptive such that as matters that affected the initial SUDS conditions may have changed, shifted, grown or otherwise be different.
(Examples are increased lesions with MS). Where initial patterns were created with a certain set of neural condition and pathways. But now days/weeks later, with new pathways created, can a previously installed DAX pattern adjust and shift to accommodate the new neural patterns based on participants willingness and self-instruction, or does it require professional adjustment.
Example participant given strong post-hypnotic suggestions/anchor/etc to squeeze right hand in certain way to bring relief to leg discomfort. Initial testing shows working. Now time has shifted, maybe new pathways or other chronic conditions have changed. Can the DAX processes the participant has been taught handle these changes or does it require a professional to re-apply/boost or incorporate new details to get significant changes to reported SUDS discomfort values.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary | – | Behavioral: Self-Hypnosis, Behavioral: Direct Autonomic Experience ControlPrimary |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Open to anyone over age or 12 (with proper adult/guardian supervision/authorization) with a proper medical chronic condition with one discomfort item (may have many, but only picking one) to be measured and evaluated over term of this study
Key inclusion criteria (8 listed)
- Participant must have a proper medical diagnosis of chronic condition.
- Existing medical treatments are having little to no effect on a discomfort metric to measure
- SUDS to be evaluated could be physical or emotional in nature (e.g. Anxiety level, or Leg Cramping/moving)
- Must be motivated and willing to participate in a study that uses hypnosis, placebo and/or nocebo type mental matters.
- Participant must continue existing medical treatments (as recommended/adjusted by such outside professionals) and continue to see and be monitored by new/existing medical professionals during the term of study.
Key exclusion criteria (3 listed)
- Acute and short term discomfort matters not being measured that outside scope of chronic condition.
- Must not be active in any other studies or such studies deemed to not interact with this.
- Does not have a properly diagnosed chronic condition (exception are control subjects)
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 |
|---|---|---|
| Self-HypnosisSelf-Hypnosis | Behavioural | Primary |
| Direct Autonomic Experience ControlAlso: DAX ControlDirect Autonomic Experience Control. Use of learned mental tool/process to affect outcome measure of SUDS discomfort experience. (eg. Squeeze hand as pre-learned mental anchor to relieve discomfort in lower legs) | Behavioural | Primary |
Primary outcome
SUDS
Time frame: 7 days
Subject Unit of Discomfort Symptom. Each patient will have different types and levels of discomfort. Could be back, legs, whatever. Once identified and a numerical value applied to level of discomfort on scale of 1 to 10. We will track that particular SUDS metric through the study, looking for various factors that enable the measured value to drop to lowest value and to re-correct back to lower value if conditions cause it to rise again.
2 secondary outcomes
DAX Control of SUDS Change
Time frame: 1 day
Professional Control of SUDS change
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Individual participant dataSharing planned: No
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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.
Martin Vendemia, BCH, MNLP principal investigator
Inner Group Inc.
Questions about this trial
What is this clinical trial studying?
An observational study of Restless Legs Syndrome and Multiple Sclerosis, run by Inner Group Inc..
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 8 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Martin Vendemia, BCH, MNLP (410-709-7449, Martin@innergroupinc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SUDS (time frame: 7 days). 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 29 Jul 2020.