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Completed

NCT Number: NCT04957563

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

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.

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Key information

Conditions

Anosmia Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Neurologic Manifestations Occupational Therapy Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

olfactory rehabilitation

Behavioral

treatment for improve olfactory function

Primary outcomes

  1. CCCRC

    Time frame: 6 months

    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 outcomes

  1. RSDI

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Cristina Gomez Calero

Other

Registry information

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2021
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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