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
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea of Adult
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
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
NCT ID
NCT03063567
First Posted
February 14, 2017
Last Updated
February 26, 2018
Sponsor
Singapore General Hospital
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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