title: Auditory and visual 3D virtual reality therapy as a new treatment for chronic subjective tinnitus: Results of a randomized controlled trial.
abstract: BACKGROUND
  Subjective tinnitus (ST) is a frequent audiologic condition that still requires effective treatment. This study aimed at evaluating two therapeutic approaches: Virtual Reality (VR) immersion in auditory and visual 3D environments and Cognitive Behaviour Therapy (CBT).
  
  
  METHODS
  This open, randomized and therapeutic equivalence trial used bilateral testing of VR versus CBT. Adult patients displaying unilateral or predominantly unilateral ST, and fulfilling inclusion criteria were included after giving their written informed consent. We measured the different therapeutic effect by comparing the mean scores of validated questionnaires and visual analog scales, pre and post protocol. Equivalence was established if both strategies did not differ for more than a predetermined limit. We used univariate and multivariate analysis adjusted on baseline values to assess treatment efficacy. In addition of this trial, purely exploratory comparison to a waiting list group (WL) was provided.
  
  
  RESULTS
  Between August, 2009 and November, 2011, 148 of 162 screened patients were enrolled (VR n = 61, CBT n = 58, WL n = 29). These groups did not differ at baseline for demographic data. Three month after the end of the treatment, we didn't find any difference between VR and CBT groups either for tinnitus severity (p = 0.99) or tinnitus handicap (p = 0.36).
  
  
  CONCLUSIONS
  VR appears to be at least as effective as CBT in unilateral ST patients.
authors.affiliation: Department of ENT and CNRS UMR 8119, Hôpital Européen Georges Pompidou, Faculté de médecine Paris Descartes, Université Paris 5, Paris, France; Center of Neurophysics, Physiology and Pathology (CN2P), CNRS UMR 8119, Université Paris Descartes, Paris, France. Electronic address: david.malinvaud@egp.aphp.fr.
authors.forename: D
authors.initials: D
authors.lastname: Malinvaud
authors.affiliation: Department of ENT and CNRS UMR 8119, Hôpital Européen Georges Pompidou, Faculté de médecine Paris Descartes, Université Paris 5, Paris, France.
authors.forename: A
authors.initials: A
authors.lastname: Londero
authors.affiliation: Assistance Publique-Hôpitaux de Paris, European Georges Pompidou Hospital, Epidemiology and Clinical Research Unit, Paris, France; INSERM, Epidemiological Investigation Center 4, Paris, France.
authors.forename: R
authors.initials: R
authors.lastname: Niarra
authors.affiliation: Department of ENT and CNRS UMR 8119, Hôpital Européen Georges Pompidou, Faculté de médecine Paris Descartes, Université Paris 5, Paris, France.
authors.forename: Ph
authors.initials: P
authors.lastname: Peignard
authors.affiliation: Sorbonne Universités, UPMC Univ Paris 06, CNRS, IRCAM, Sciences et Techniques de la Musique et du Son, Paris, France.
authors.forename: O
authors.initials: O
authors.lastname: Warusfel
authors.affiliation: Sorbonne Universités, UPMC Univ Paris 06, CNRS, IRCAM, Sciences et Techniques de la Musique et du Son, Paris, France.
authors.forename: I
authors.initials: I
authors.lastname: Viaud-Delmon
authors.affiliation: Assistance Publique-Hôpitaux de Paris, European Georges Pompidou Hospital, Epidemiology and Clinical Research Unit, Paris, France; INSERM, Epidemiological Investigation Center 4, Paris, France.
authors.forename: G
authors.initials: G
authors.lastname: Chatellier
authors.affiliation: Department of ENT and CNRS UMR 8119, Hôpital Européen Georges Pompidou, Faculté de médecine Paris Descartes, Université Paris 5, Paris, France; Cognition and Action Group, CNRS MD 8257, SSA and University Paris 5, Paris, France.
authors.forename: P
authors.initials: P
authors.lastname: Bonfils
mesh_terms: D000328:Adult; D000368:Aged; D001307:Auditory Perception; D002908:Chronic Disease; D015928:Cognitive Behavioral Therapy; D003196:Computer Graphics; D004185:Disability Evaluation; D005260:Female; D006801:Humans; D021621:Imaging, Three-Dimensional; D008297:Male; D008875:Middle Aged; D010297:Paris; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires; D013997:Time Factors; D014012:Tinnitus / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D016896:Treatment Outcome; D063367:Virtual Reality Exposure Therapy; D014796:Visual Perception
keywords: Cognitive behaviour therapy; Subjective tinnitus; Virtual reality