Back to resultsClinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia
Primary Purpose
Anosmia, Occupational Therapy, Brain Injuries, Traumatic
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
olfactory rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Anosmia focused on measuring occupational therapy, anosmia, brain injuries, traumatic
Eligibility Criteria
Inclusion Criteria:
- Olfactory loss participants from institution to the Smell & Tast Office, Otorhinolaryngology Unit, Hospital Universitario Fundación Alcorcón.
All participants provided written informed consent
Exclusion Criteria:
- No sign informed consent
Sites / Locations
- Hospital Universitario Fundación Alcorcón
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
experimental rehabilitation
control
Arm Description
recived olfactory rehabilitation
withouth olfactory rehabilitation
Outcomes
Primary Outcome Measures
CCCRC
the Connecticut Chemosensorial Clinical Research Centre test (CCCRC) Cain, W.S., Goodspeed, R.B., Gent, J.F. & Leonard, G. (1988). Evaluation of olfactory dysfunction in the Connecticut Clinical Chemosensory Research Centre. Laryngoscope, 98:83-8. https://doi.org/10.1288/00005537-198801000-00017
Secondary Outcome Measures
RSDI
Rhinosinusitis Disability Index. The Rhinosinusitis Disability Index (RSDI) is a 30-item, Likert-scale survey consisting of three individual subscales that include the physical, functional, and emotional domains. Total scores range between 0-120. Higher RSDI total and domain scores imply a higher impact of disease
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04957563
Brief Title
Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia
Official Title
Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
October 20, 2009 (Actual)
Primary Completion Date
October 20, 2014 (Actual)
Study Completion Date
October 20, 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cristina Gomez Calero
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of our study was to compare the recovery of smell in people suffering posttraumatic olfactory impairment following a systematic olfactory rehabilitation performed by occupational therapists to natural recovery in a control posttraumatic group of patients.
Detailed Description
Forty participants started the study: 20 for the control group and 20 for the treatment group. The mean of the time span between the traumatic event and the first visit in the rehabilitation group was longer than 22 months, time enough to wait any kind of spontaneous recovery.
In order to establish correct comparisons, the investigators analyzed whether both groups of participants (control group and treatment group) were homogeneous or not regarding the age, gender, time span between the traumatic event and the first visit to the office, brain damage and loss of conscience. Investigators administered visual analogic scale (VAS), CCCRC olfactory test and quality of life questionnaire (RSDI) to both groups at the beginning of the study and 12 months late
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anosmia, Occupational Therapy, Brain Injuries, Traumatic
Keywords
occupational therapy, anosmia, brain injuries, traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
control group and experimental group
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
experimental rehabilitation
Arm Type
Experimental
Arm Description
recived olfactory rehabilitation
Arm Title
control
Arm Type
No Intervention
Arm Description
withouth olfactory rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
olfactory rehabilitation
Intervention Description
treatment for improve olfactory function
Primary Outcome Measure Information:
Title
CCCRC
Description
the Connecticut Chemosensorial Clinical Research Centre test (CCCRC) Cain, W.S., Goodspeed, R.B., Gent, J.F. & Leonard, G. (1988). Evaluation of olfactory dysfunction in the Connecticut Clinical Chemosensory Research Centre. Laryngoscope, 98:83-8. https://doi.org/10.1288/00005537-198801000-00017
Time Frame
6 months
Secondary Outcome Measure Information:
Title
RSDI
Description
Rhinosinusitis Disability Index. The Rhinosinusitis Disability Index (RSDI) is a 30-item, Likert-scale survey consisting of three individual subscales that include the physical, functional, and emotional domains. Total scores range between 0-120. Higher RSDI total and domain scores imply a higher impact of disease
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Olfactory loss participants from institution to the Smell & Tast Office, Otorhinolaryngology Unit, Hospital Universitario Fundación Alcorcón.
All participants provided written informed consent
Exclusion Criteria:
No sign informed consent
Facility Information:
Facility Name
Hospital Universitario Fundación Alcorcón
City
Alcorcón
State/Province
Madrid
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia
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