AnorexiaNCT02793102
Sensory Workshops and Anorexia Nervosa
A study testing Olfactory workshop, Somesthesia workshop and Auditory workshop in people with Anorexia, run by Fondation Lenval.
Trial summary
In the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Anorexia
- What is being tested?
- Olfactory workshop, Somesthesia workshop and Auditory workshop
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2012to Mar 2015
- 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 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosis of anorexia nervosa according to DMS IV-TR (Diagnostic and Statistical Manual of Mental Disorders) criteria.
- Follow Outpatient care or hospitalization
- Able to respond to the clinical evaluation questionnaires
- Affiliated to the social security system
- Consentement Informed of the legal representative and the patient
Who cannot join
- Somatic comorbidity associated diabetes, celiac disease, brain tumor.
- Intolerance Odors, predisposition to develop asthma and / or respiratory allergies.
- Pathologie Chronic of nose and sinus.
- Hyposmic Or anosmic.
About this study
Official title: Prospective Evaluation of a Year of Therapeutic Impact Sensory Workshops on Body Mass Index in Anorexia Adolescent Mental
In the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.
Read the detailed description
As part of the unit that specializes in eating disorders in adolescents, we see patients decreased taste and smell sensory abilities. Since 2006, we have implemented various sensory workshops: olfactory, tactile-kinesthetic and auditory. The establishment of this therapeutic practice that is centered on oral sphere and all respect, it was observed a decrease of 30% of the length of hospitalization. All the data we currently have in the field, suggests a rehabituation food odors and facilitate the recall of memories related to food in anorexic patients. However in the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.
- Conditions
- Anorexia
- Being tested
- Olfactory workshop, Somesthesia workshop, Auditory workshop
- Keywords
- mental anorexia, sensory workshops, BMI
- Medical subject headings
- Anorexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Olfactory workshopOther
Twenty odorants are selected: 10 evoke a food (including 5 pleasant and unpleasant 5) and 10 suggest a non-food source
Somesthesia workshopOther
Kinesthetic time or time for moving the body (30 min), and kinesthetic sensations (duration 10 min), and Talk Time
Auditory workshopOther
Twenty extracts of music tracks (30 seconds each) are built in the same fashion as those used during the workshops, but are different.
| Study group | Role | What they receive |
|---|---|---|
| Olfactory workshop + Somesthesia workshop | Experimental | Olfactory workshop, Twenty odorants. Somesthesia workshop, time for moving the body, Talk Time Receives: Other: Olfactory workshop; Other: Somesthesia workshop |
| Auditory workshop + Somesthesia workshop | Experimental | Auditory workshop, Twenty extracts of music tracks. Somesthesia workshop, time for moving the body, Talk Time Receives: Other: Somesthesia workshop; Other: Auditory workshop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the impact of sensory workshops on BMI Body Mass Indexat 6 months and 12 months
The primary endpoint is the M6 and increase maintenance M12 BMI Body Mass Index to <or = 2.6kg / m2
Measured: Comparaison to baseline and 6 month after and maintenance at month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2016 (estimated)
- Study startSep 2012
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Lack of patient responding to criteria
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnorexiaStudies 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Lenval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence ASKENAZY, MD, Principal investigator, Fondation Lenval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02793102
- Sponsor's protocol ID
- 14-HPNCL-11
- Status last verified
- Jun 2016
- First submitted
- 3 Jun 2016
- Last updated
- 8 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of a Year of Therapeutic Impact Sensory Workshops on Body Mass Index in Anorexia Adolescent Mental
- ClinicalTrials.gov ID
- NCT02793102
- Acronym / sponsor ID
- 14-HPNCL-11
- Conditions
- Anorexia
- Keywords
- mental anorexia, sensory workshops, BMI
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of patient responding to criteria
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fondation LenvalUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 8 Jun 2016 (estimated)
- 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.
In the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.
Detailed description
As part of the unit that specializes in eating disorders in adolescents, we see patients decreased taste and smell sensory abilities. Since 2006, we have implemented various sensory workshops: olfactory, tactile-kinesthetic and auditory. The establishment of this therapeutic practice that is centered on oral sphere and all respect, it was observed a decrease of 30% of the length of hospitalization. All the data we currently have in the field, suggests a rehabituation food odors and facilitate the recall of memories related to food in anorexic patients. However in the literature the use of olfactory dimension in the treatment of anorexia has not been verified experimentally. The investigator hypothesize that the therapeutic use of a dietary nature olfactory stimuli in anorexia nervosa promotes food recovery. The team propose a prospective study over a period of 12 months in which we use the Body Mass Index (BMI) as the primary endpoint of the state of anorexia nervosa patients.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Olfactory workshop + Somesthesia workshop | Experimental | Other: Olfactory workshop, Other: Somesthesia workshopOlfactory workshop, Twenty odorants. Somesthesia workshop, time for moving the body, Talk Time |
| Auditory workshop + Somesthesia workshop | Experimental | Other: Somesthesia workshop, Other: Auditory workshopAuditory workshop, Twenty extracts of music tracks. Somesthesia workshop, time for moving the body, Talk Time |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Diagnosis of anorexia nervosa according to DMS IV-TR (Diagnostic and Statistical Manual of Mental Disorders) criteria.
- Follow Outpatient care or hospitalization
- Able to respond to the clinical evaluation questionnaires
- Affiliated to the social security system
- Consentement Informed of the legal representative and the patient
Key exclusion criteria (4 listed)
- Somatic comorbidity associated diabetes, celiac disease, brain tumor.
- Intolerance Odors, predisposition to develop asthma and / or respiratory allergies.
- Pathologie Chronic of nose and sinus.
- Hyposmic Or anosmic.
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 |
|---|---|---|
| Olfactory workshopTwenty odorants are selected: 10 evoke a food (including 5 pleasant and unpleasant 5) and 10 suggest a non-food source | Other | Olfactory workshop + Somesthesia workshop |
| Somesthesia workshopKinesthetic time or time for moving the body (30 min), and kinesthetic sensations (duration 10 min), and Talk Time | Other | Auditory workshop + Somesthesia workshop, Olfactory workshop + Somesthesia workshop |
| Auditory workshopTwenty extracts of music tracks (30 seconds each) are built in the same fashion as those used during the workshops, but are different. | Other | Auditory workshop + Somesthesia workshop |
Primary outcome
Assess the impact of sensory workshops on BMI Body Mass Indexat 6 months and 12 months
Time frame: Comparaison to baseline and 6 month after and maintenance at month 12
The primary endpoint is the M6 and increase maintenance M12 BMI Body Mass Index to <or = 2.6kg / m2
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2016.
- Individual participant dataSharing planned: No
Related trials for Anorexia
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Cerebellar tDCS Stimulation in Children and Adult Women With Anorexia Nervosa Disorder
Anorexia Nervosa
RecruitingObservational study
Exploratory Study of Sensory Profile and Coping Strategies in Eating Disorders
Eating Disorders, Anorexia Nervosa
Recruiting
Identification of Anti-HIF 1alpha Autoantibodies in Patients With Anorexia Nervosa and Characterization of Their Pathogenic Potential in Undernutrition-associated Hepatic Cytolysis
Hepatic Cytolysis
Not yet recruitingPhase 2/3
Master Protocol for the Study of Rilogrotug for the Treatment of Weight Loss and Anorexia in Patients With Cancer Cachexia and mCRC or mNSCLC
Cachexia; Cancer, Cachexia
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.
Florence ASKENAZY, MD principal investigator
Fondation Lenval
Questions about this trial
What is this clinical trial studying?
A study testing Olfactory workshop, Somesthesia workshop and Auditory workshop in people with Anorexia, run by Fondation Lenval.
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 5 inclusion and 4 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: withdrawn, as of the sponsor's last update on 8 Jun 2016. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Assess the impact of sensory workshops on BMI Body Mass Indexat 6 months and 12 months (time frame: Comparaison to baseline and 6 month after and maintenance at month 12). 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 8 Jun 2016.