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Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)

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ClinicalTrials.gov Identifier: NCT02486380
Recruitment Status : Terminated (Recruitment terminated permanently due to limited resource to recruit.)
First Posted : July 1, 2015
Last Update Posted : June 24, 2022
Sponsor:
Information provided by (Responsible Party):
Fisher and Paykel Healthcare

Study Description
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Brief Summary:
This investigation is to evaluate the performance, comfort and ease of use of the Toffee full face and toffee nasal mask masks amongst Obesity Hypoventilation Syndrome (OHS) patients in an overnight study.

Condition or disease Intervention/treatment Phase
Obesity Hypoventilation Syndrome Device: Toffee full face mask/toffee nasal mask Not Applicable

Detailed Description:
Up to 20 OHS patients who currently use a full face mask or a nasal mask will be recruited. They will be issued a F&P Toffee Full face (if they are existing full face users) or F&P Toffee Nasal (if they are existing nasal users) for an overnight polysomnography.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Toffee Full Face and Toffee Nasal Mask Evaluation in Obesity Hypoventilation Syndrome (NZ)
Study Start Date : July 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: Full face/Nasal masks
Toffee Full face/Toffee nasal
 Device: Toffee full face mask/toffee nasal mask
Toffee full face mask/toffee nasal mask


Outcome Measures
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Primary Outcome Measures :
  1. Objective Leak data [ Time Frame: 1 night ]
    Obtained from the participant's device and polysomnography (PSG)


Secondary Outcome Measures :
  1. Subjective measurement of Leak [ Time Frame: 1 night ]
    Questionnaire

  2. Comfort [ Time Frame: 1 night ]
    Questionnaire

  3. Ease of use [ Time Frame: 1 night ]
    Questionnaire

  4. Sleep efficiency [ Time Frame: 1 night ]
    Obtained through the PSG

  5. Wake after Sleep Onset (WASO) [ Time Frame: 1 night ]
    Obtained through the PSG

  6. Arousal Index (AI) [ Time Frame: 1 night ]
    Obtained through the PSG


Eligibility Criteria
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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:

  • Aged 18+
  • Diagnosed with OHS by a practicing physician
  • Existing full face mask user or a nasal mask user
  • Prescribed PAP therapy (Bi-Level or CPAP)

Exclusion Criteria:

  • Inability to give informed consent
  • Pregnant or think they may be pregnant
  • Anatomical or physiological conditions making PAP therapy inappropriate
  • Patients requiring supplemental oxygen with their PAP device
  • Patients who are in a coma or decreased level of consciousness
  • Existing Toffee full face and Toffee nasal mask users
  • No arterial PCO2 value from their medical records
Contacts and Locations
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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): NCT02486380


Locations
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New Zealand
Fisher & Paykel Healthcare
Auckland, New Zealand, 2013
Sponsors and Collaborators
Fisher and Paykel Healthcare
Investigators
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Principal Investigator: Bhavi Ogra, BSc Fisher & Paykel Healthcare
More Information
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Responsible Party: Fisher and Paykel Healthcare
ClinicalTrials.gov Identifier: NCT02486380    
Other Study ID Numbers: CIA-162
First Posted: July 1, 2015    Key Record Dates
Last Update Posted: June 24, 2022
Last Verified: June 2022
Additional relevant MeSH terms:
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Hypoventilation
Obesity Hypoventilation Syndrome
Obesity
Syndrome
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Respiratory Insufficiency
 Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases