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Investigation of Predictive Indices to Objectively Guide Choice of CPAP Interface

Primary Purpose

Obstructive Sleep Apnea of Adult

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CPAP interfaces
Sponsored by
Singapore General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea of Adult

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with OSA of at least moderate severity (Apnea hypopnea index (AHI) score of ≥15 on baseline polysomnography with ESS ≥ 10 or AHI≥30 regardless of ESS).
  2. Patients with no previous experience with CPAP.
  3. Patients who are between 21 - 90 year old

Exclusion Criteria:

  1. Patients with significant orofacial problems that preclude the use of the interfaces.
  2. Patients who did not consent to participate in study or are unable to give informed consent.
  3. Patients with significant underlying cardiorespiratory disease that will preclude the use of AutoPAP mode of ventilation for treatment of OSA.
  4. Patients who cannot tolerate a 5minute quick trial of the interface during counselling
  5. Pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    one month trial of Nasal Mask

    One month trial of Oronasal mask

    One month trial of Nasal pillows

    Arm Description

    All patients in study underwent crossover prospective trial of the same 3 types of CPAP interfaces in randomized order. Trial was 1 month duration for each interface.

    All patients in study underwent crossover prospective trial of the same 3 types of CPAP interfaces in randomized order. Trial was 1 month duration for each interface.

    All patients in study underwent crossover prospective trial of the same 3 types of CPAP interfaces in randomized order. Trial was 1 month duration for each interface.

    Outcomes

    Primary Outcome Measures

    Choice of preferred interface at the end of the one monthly trial of the 3 interfaces

    Secondary Outcome Measures

    Level of satisfaction (assessed with visual analogue scale) with each interface
    Amount of leak for each interface
    Hours of adherence for each interface
    Compliance with the chosen interface at 6 month follow-up
    Assessed with downloaded data from the CPAP machine on Percentage of days with usage of more than 4 hours, mean average usage per night

    Full Information

    First Posted
    February 14, 2017
    Last Updated
    February 26, 2018
    Sponsor
    Singapore General Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03063567
    Brief Title
    Investigation of Predictive Indices to Objectively Guide Choice of CPAP Interface
    Official Title
    Selecting the Appropriate CPAP Interface: Investigation of Predictive Indices to Objectively Guide the Choice of Interface
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (Actual)
    Primary Completion Date
    January 31, 2017 (Actual)
    Study Completion Date
    March 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Singapore General Hospital

    4. Oversight

    5. Study Description

    Brief Summary
    Obstructive sleep apnea (OSA) is a prevalent disease, and one that is associated with significant negative impact on long-term survival. There is convincing evidence that treatment of OSA can improve outcome in patients with cardiovascular disease, improve blood pressure and blood glucose control, and improve the overall metabolic syndrome. Treatment is usually with continuous positive airway pressure (CPAP). However, many patients face problems with their CPAP interfaces, affecting their compliance and response to treatment. Proper mask fit is important in decreasing air leak and increasing comfort, thus leading to better compliance. Currently, the choice of interfaces depends mainly on the experience of the sleep disorder unit (SDU) technicians. Unsuitable choice of interface not only affects response to treatment but also increases medical costs when interfaces need to be replaced to better fitting ones. It is thus important to develop selection criteria to objectively guide the SDU technicians in choosing the suitable interfaces. The objective of this study is to study the facial profile of patients and look for predictive indices that can be used to objectively guide the choice of appropriate interfaces. Frontal and side profile photographs of patients will be taken and facial measurements will be recorded. Patients will then be given a one monthly trial of each of the 3 interfaces (nasal masks, oronasal masks, nasal cushions) in a randomised order. The patients' subjective perception of each of the interface will be assessed and patients will nominate their preferred interface at the end of the trial. The amount of leak and the hours of adherence for each type of interface will also be analysed. A multinomial logistic regression analysis will then be done to look for facial measurements that will predict the interface that patients will be most satisfied with. Hypothesis That measurement of facial structures and clinical features will be able to predict the best-fit CPAP interface for each patient. Study Objective To determine anthropometric facial measurements and clinical factors important in achieving a good interface fit for each patient To derive a prediction rule or equation that will be able to accurately predict which interface a patient should be prescribed
    Detailed Description
    This clinical research will be a prospective crossover trial in which frontal and side facial profile photographs of patients will be taken and facial measurement will be recorded including the height and width of the face and nose. Body Mass Index (BMI), Apnea Hypopnea Index (AHI) and Epworth Sleepiness Score(ESS) will be recorded. Baseline symptoms of mouth breathing and nasal congestion will also be assessed. Patients will undergo a quick 5minute trial of the interfaces at CPAP setting of 6cm H2O and give feedback of their preferred interface and satisfaction of each interface (Visual analogue scale) at the end of the quick trial. Patients will then be given a one month trial of each of the 3 interfaces (nasal masks, oronasal masks, nasal cushions) in a randomised order. For purpose of standardisation to avoid confounders, humidification and auto-titrating CPAP (autoPAP) mode of ventilation will be used in all patients. The brand of interfaces and CPAP devices used will also be standardised. This standardised CPAP treatment will be provided free of charge to patients during the duration of the study (3 months). The patients' subjective perception of each of the interface will be assessed with a visual analogue scale to assess level of satisfaction. Patients will nominate their preferred interface at the end of the trial. The amount of leak and the hours of adherence to CPAP for each type of interface will also be analysed by downloading data from the CPAP devices. A multinomial logistic regression analysis will then be done to look for facial measurements and factors that will predict the interface that patients will be most satisfied with.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obstructive Sleep Apnea of Adult

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Prospective crossover trial. All patients will undergo a one month trial of each of the 3 interfaces (nasal masks, oronasal masks, nasal cushions) in a randomised order.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    one month trial of Nasal Mask
    Arm Type
    Other
    Arm Description
    All patients in study underwent crossover prospective trial of the same 3 types of CPAP interfaces in randomized order. Trial was 1 month duration for each interface.
    Arm Title
    One month trial of Oronasal mask
    Arm Type
    Other
    Arm Description
    All patients in study underwent crossover prospective trial of the same 3 types of CPAP interfaces in randomized order. Trial was 1 month duration for each interface.
    Arm Title
    One month trial of Nasal pillows
    Arm Type
    Other
    Arm Description
    All patients in study underwent crossover prospective trial of the same 3 types of CPAP interfaces in randomized order. Trial was 1 month duration for each interface.
    Intervention Type
    Device
    Intervention Name(s)
    CPAP interfaces
    Intervention Description
    All patients in study underwent crossover prospective trial of the same 3 types of CPAP interfaces (nasal mask, oronasal mask, nasal pillows) in randomized order. Trial was 1 month duration for each interface.
    Primary Outcome Measure Information:
    Title
    Choice of preferred interface at the end of the one monthly trial of the 3 interfaces
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    Level of satisfaction (assessed with visual analogue scale) with each interface
    Time Frame
    1 month
    Title
    Amount of leak for each interface
    Time Frame
    1 month
    Title
    Hours of adherence for each interface
    Time Frame
    1 month
    Title
    Compliance with the chosen interface at 6 month follow-up
    Description
    Assessed with downloaded data from the CPAP machine on Percentage of days with usage of more than 4 hours, mean average usage per night
    Time Frame
    6 month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with OSA of at least moderate severity (Apnea hypopnea index (AHI) score of ≥15 on baseline polysomnography with ESS ≥ 10 or AHI≥30 regardless of ESS). Patients with no previous experience with CPAP. Patients who are between 21 - 90 year old Exclusion Criteria: Patients with significant orofacial problems that preclude the use of the interfaces. Patients who did not consent to participate in study or are unable to give informed consent. Patients with significant underlying cardiorespiratory disease that will preclude the use of AutoPAP mode of ventilation for treatment of OSA. Patients who cannot tolerate a 5minute quick trial of the interface during counselling Pregnancy
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rui Ya Soh
    Organizational Affiliation
    Singhealth Foundation
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Thun How Ong
    Organizational Affiliation
    Singhealth Foundation
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    30189465
    Citation
    Goh KJ, Soh RY, Leow LC, Toh ST, Song PR, Hao Y, Lee KCH, Tan GL, Ong TH. Choosing the right mask for your Asian patient with sleep apnoea: A randomized, crossover trial of CPAP interfaces. Respirology. 2019 Mar;24(3):278-285. doi: 10.1111/resp.13396. Epub 2018 Sep 6.
    Results Reference
    derived

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    Investigation of Predictive Indices to Objectively Guide Choice of CPAP Interface

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