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Systematic Laryngoscopic Evaluation of Upper Airways in Ventilated ALS Patients in Portugal and in Norway

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ClinicalTrials.gov Identifier: NCT03887338
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : March 22, 2019
Sponsor:
Collaborators:
University of Trás-os-Montes and Alto Douro
Universidade do Porto
Haukeland University Hospital
Information provided by (Responsible Party):
Tiina Maarit Andersen, Haukeland University Hospital

Brief Summary:
The study examines if titration of Non-Invasive mechanical ventilation (NIV) settings during ongoing laryngoscopic visualization can improve the compliance of NIV in subjects with Amyotrophic Lateral Sclerosis (ALS). The study is a multicentre study between Norwegian National Advisory Unit on Long-term Mechanical Ventilation at the Thoracic Department, Haukeland University Hospital, Bergen, Norway and Centro Hospital Tras-os-Montes e Alto Douro, Vila Real, Portugal.

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Other: Transnasal Fiberoptic Laryngoscopy Not Applicable

Detailed Description:

ALS, amyotrophic lateral sclerosis, is a rare and fatal disease causing gradual loss of motor neurons and thus loss of function in all skeletal muscle, eventually also in the breathing muscles, leading to respiratory failure and ultimately death. There is no causal treatment. The treatment provided aims to improve life quality as long as possible. Non-invasive ventilation (NIV) compensates for respiratory failure as breathing deteriorates.

ALS patients with bulbar innervated muscle dysfunction (mouth, tongue, jaw, throat, larynx) have poor compliance to the use of NIV. It is not completely understood why bulbar ALS patients fails NIV, although the upper airways have been a suggested cause also of this treatment failure. The investigators in the Norwegian study group has previously examined laryngeal response patterns (using transnasal fiberoptic laryngoscopy ) during mechanically assisted cough in ALS. The studies revealed that Transnasal fiberoptic laryngoscopy was safely performed with ongoing mechanically assisted cough, and it appeared a feasible tool to visualize the laryngeal responses to mechanical cough therapy.

The further hypothesis is that the use of transnasal fiberoptic laryngoscopy during ongoing NIV titration could improve the compliance of NIV treatment in ALS.

Since ALS is a relatively rare disease and it is difficult to perform large clinical studies, a project group has been established and agreed to a common protocol of a population-based multicenter-study including two hospitals, in Bergen in Norway and Vila Real in Portugal.

Aims of the study are:

To investigate the feasibility of video-recorded Transnasal fiberoptic laryngoscopic evaluation of the upper airways applied during NIV titration, and to describe the upper airway responses to NIV treatment in patients with ALS.

To explore whether the endoscopic view of the upper airways will influence the titration of NIV settings in ALS patients.

To explore whether NIV titration with endoscopic evaluation will influence NIV compliance and ventilation effectiveness in ALS patients.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All the subjects will receive the same intervention, and they will be examined both prior to the intervention, one month after and three months after the intervention. They will act as they own controls.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Systematic Laryngoscopic Evaluation of Upper Airways in Ventilated Amyotrophic Lateral Sclerosis (ALS) Patients in Portugal and in Norway
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
NIV settings titration
Transnasal Fiberoptic Laryngoscopy will be used during ongoing NIV setting titration. Aim is to titrate NIV setting to be more optimal for laryngeal responses.
Other: Transnasal Fiberoptic Laryngoscopy
Use of Transnasal Fiberoptic Laryngoscopy during NIV titration to optimalize the NIV settings to laryngeal responses during the NIV treatment.




Primary Outcome Measures :
  1. Apnoea-hypopnea index (AHI) [ Time Frame: Baseline, one and three months after the intervention. ]
    Change in number of apnea and hypopnea events per hour of sleep

  2. Time of NIV use [ Time Frame: Baseline, one and three months after the intervention. ]
    Change in median daily and average daily of hours, minutes

  3. NIV Leaks [ Time Frame: Baseline, one and three months after the intervention. ]
    Change in median and 95%

  4. NIV time of use [ Time Frame: Baseline, one and three months after the intervention. ]
    Change in % of time of use > than 4 hours/day

  5. NIV compliance [ Time Frame: Baseline, one and three months after the intervention. ]
    Change in number of interruptions, complains and ventilator adjustments


Secondary Outcome Measures :
  1. Night-time pulseoximeter [ Time Frame: Baseline, one and three months after the intervention. ]
    Change in oxygen saturation of patients blood

  2. Night-time capnography [ Time Frame: Baseline, one and three months after the intervention. ]
    Change in concentration or partial pressure of carbon dioxide in the respiratory gases



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients diagnosed Amyotrophic Lateral Sclerosis (ALS) due to El Escorial criteria
  • Must have already established Non-invasive ventilation (NIV)

Exclusion Criteria:

  • Ages under 18 years
  • Unstable ischemic heart disease
  • Oncological disease
  • Ventilatory support dependency (more than 16h per day)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887338


Contacts
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Contact: Tiina M Andersen, PhD +4755978486 tiina.andersen@helse-bergen.no
Contact: Bebiana Conde, PhD fellow +351936305294 bebianaconde@gmail.com

Locations
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Norway
Norwegian National Advisory Unit on Long-term Mechanical Ventilation at Thoracic Department, Haukeland University Hospital Recruiting
Bergen, Hordaland, Norway, 5021
Contact: Tiina M Andersen, PhD       tiina.andersen@helse-bergen.no   
Principal Investigator: Tiina M Andersen, PhD         
Sub-Investigator: Maria Vollsæter, PhD         
Sub-Investigator: Ove Fondenes, MD         
Portugal
Centro Hospitalar Tras-os-Montes e Alto Douro Recruiting
Vila Real, Portugal
Contact: Bebiana Conde, PhD fellow       bebianaconde@gmail.com   
Principal Investigator: Bebiana Conde, PhD fellow         
Sub-Investigator: Joao Winck, Professor         
Sponsors and Collaborators
Tiina Maarit Andersen
University of Trás-os-Montes and Alto Douro
Universidade do Porto
Haukeland University Hospital
Investigators
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Principal Investigator: Tiina M Andersen, PhD Haukeland University Hospital
Principal Investigator: Bebiana Conde, PhD fellow Centro Hospitalar Tras-os-Montes e Alto Douro

Publications:
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Responsible Party: Tiina Maarit Andersen, Respiratory Physiotherapist, PhD, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT03887338     History of Changes
Other Study ID Numbers: 2018/1306
39/2016 ( Other Identifier: Centro Hospitalar Trás-os-Montes e Alto Douro, Vila Real )
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Since the study examines patients with a rare disease in the defined geographical areas, we need to be careful not to share data that can be identifiable. A study protocol, informed consent forms and data analysis plan will be available within 6 months of study completion.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tiina Maarit Andersen, Haukeland University Hospital:
Noninvasive Ventilation
Laryngoscopy

Additional relevant MeSH terms:
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Sclerosis
Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases