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High-intensity Group Vocal Exercise to Improve Laryngeal Function in Patients With Parkinson Disease

23. august 2018 opdateret af: NYU Langone Health

The overall goal of this T2 translational research project is to pilot an interdisciplinary high-intensity group singing program to improve speech and swallowing in patients with Parkinson's Disease (PD) and to explore the impact of this program on quality of life (QOL). This research has three specific aims: 1) Determine the effects of a high-intensity group vocal training program on vocal function and laryngeal structure; 2) Determine the transference of vocal training to laryngeal aspects of swallowing; 3) Determine the effect of patient-reported changes in Quality of Life (QOL) as the result of participation in a group vocal training program.

Twenty patients with Parkinson Disease will be recruited from the Fresco Institute for Parkinson's & Movement Disorders to participate in a 12-week vocal training program. The program will train participants using maximum vocal function exercises targeting vocal deficits specific to PD. Choral singing therapy sessions will be conducted once weekly with daily home practice exercises based on principles that have been successful in other intensive PD vocal exercise programs.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

Deterioration of speech and swallowing is a hallmark of Parkinson Disease (PD). There is emerging evidence that choral singing benefits people with PD across a range of modalities. Despite the increasing popularity of "Parkinson's choirs", rigorous study of these benefits is lacking. There is a large body of evidence that intense vocal training improves speech and communication for people with PD. However, the intense training places high demands on clinical and patient resources and, due to its individualized approach, lacks the potential psycho-social benefits of a group intervention.

It is hypothesized singing training program will increase vocal loudness, range of articulation, and prosodic variation during speech. Additionally, given existing evidence for neuroplastic transference of voice-related interventions to swallowing function, laryngeal components of swallowing function will also improve post-intervention. Finally, investigators expect to see improvements in patient-reported QOL measures corresponding with improved speech and laryngeal function and/or as the result of group interaction.

All participants will complete a standardized battery of assessment pre- and post- treatment including acoustic and aerodynamic assessment of voice, dynamic magnetic resonance imaging of speech and swallowing, and videofluoroscopic evaluation of swallowing. The outcome of this work will be a rigorous understanding of how choral singing therapy can positively impact the voice, swallowing function, and quality of life for patients with PD.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • New York
      • New York, New York, Forenede Stater, 10016
        • New York University School of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 100 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Confirmed diagnosis of Stage One, Two or Three on the Hoehn and Yahr Staging of Parkinson's Disease
  • Current swallowing severity of normal, mild, or moderate without aspiration
  • Stable regimen of anti-PD medication for >30 days

Exclusion Criteria:

  • Prior voice and/or swallowing therapy related to PD
  • History of head and neck cancer
  • History of oropharyngeal or laryngeal surgery
  • Current or former smoker (quit < 5 years)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Behavioral vocal training
12-week vocal training program will use maximum vocal function exercises targeting vocal deficits specific to Parkinson Disease.
Choral (group) singing therapy sessions will be conducted once weekly and daily home practice exercises will be assigned. All vocal exercises are based on principles that have been successful in other intensive Parkinson Disease vocal exercise programs.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Average speaking intensity (dB SPL)
Tidsramme: 19 Weeks
Tasks: Sustained phonation of /a/ at a comfortable pitch and loudness for 4 seconds; pitch glide throughout physiologic vocal range on /a/; standardized reading passage (CAPE-V sentences); 1-minute monologue in response to an emotionally neutral question; singing a standard song.
19 Weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Aaron Johnson, MD, NYU Langone Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

22. august 2017

Primær færdiggørelse (Faktiske)

13. december 2017

Studieafslutning (Faktiske)

13. december 2017

Datoer for studieregistrering

Først indsendt

24. august 2017

Først indsendt, der opfyldte QC-kriterier

24. august 2017

Først opslået (Faktiske)

28. august 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

23. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Parkinsons sygdom

Kliniske forsøg med Choral (group) singing therapy sessions

3
Abonner