NCT02486380

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 25, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 1, 2015

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

June 24, 2022

Status Verified

June 1, 2022

Enrollment Period

1.7 years

First QC Date

June 25, 2015

Last Update Submit

June 19, 2022

Conditions

Obesity Hypoventilation Syndrome

Outcome Measures

Primary Outcomes (1)

  • Objective Leak data

    Obtained from the participant's device and polysomnography (PSG)

    1 night

Secondary Outcomes (6)

  • Subjective measurement of Leak

    1 night

  • Comfort

    1 night

  • Ease of use

    1 night

  • Sleep efficiency

    1 night

  • Wake after Sleep Onset (WASO)

    1 night

  • +1 more secondary outcomes

Study Arms (1)

Full face/Nasal masks

EXPERIMENTAL

Toffee Full face/Toffee nasal

Device: Toffee full face mask/toffee nasal mask

Interventions

Toffee full face mask/toffee nasal maskDEVICE

Toffee full face mask/toffee nasal mask

Full face/Nasal masks

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fisher & Paykel Healthcare

Auckland, 2013, New Zealand

Location

MeSH Terms

Conditions

Obesity Hypoventilation Syndrome

Condition Hierarchy (Ancestors)

Sleep Apnea, ObstructiveSleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesHypoventilationRespiratory InsufficiencySleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Bhavi Ogra, BSc

    Fisher & Paykel Healthcare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

July 1, 2015

Study Start

July 1, 2015

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

June 24, 2022

Record last verified: 2022-06

Locations

NZ(1)