Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia

Brain Injuries, Traumatic Clinical Trial

Official title:

Clinical Utility of Olfactory Rehabilitation: Treatment for Pacients With Neurosensorial Anosmia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04957563
• Other study ID #: 09/79 (HUFA)
• Status: Completed
• Phase: N/A
• Start date: October 20, 2009
• Est. completion date: October 20, 2014

Study information

• Verified date: June 2021
• Source: Universidad Rey Juan Carlos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 20, 2014
• Est. primary completion date: October 20, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anosmia
• Brain Injuries
• Brain Injuries, Traumatic
• Occupational Therapy
• Olfaction Disorders

Intervention

Behavioral:
• olfactory rehabilitation
treatment for improve olfactory function

Locations

Country	Name	City	State
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Cristina Gomez Calero

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 months
Secondary	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	6 months