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Obstructive Sleep Apnea of AdultNCT03063567

Investigation of Predictive Indices to Objectively Guide Choice of CPAP Interface

A study testing CPAP interfaces in people with Obstructive Sleep Apnea of Adult, run by Singapore General Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 20 to 90 years
Conditions the study is for
Obstructive Sleep Apnea of Adult
What is being tested?
CPAP interfaces
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
No sites listed yet
Study dates
Aug 2014to 30 Mar 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

About this study

Official title: Selecting the Appropriate CPAP Interface: Investigation of Predictive Indices to Objectively Guide the Choice of Interface

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.

Read more

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
Read the 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.

Being tested
CPAP interfaces

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CPAP interfacesDevice

    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.

Study groups in NCT03063567
Study groupRoleWhat they receive
one month trial of Nasal MaskOtherAll 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.
Receives: Device: CPAP interfaces
One month trial of Oronasal maskOtherAll 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.
Receives: Device: CPAP interfaces
One month trial of Nasal pillowsOtherAll 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.
Receives: Device: CPAP interfaces

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 6 month

Secondary outcomes (4)

  1. Level of satisfaction (assessed with visual analogue scale) with each interface

    Measured: 1 month

  2. Amount of leak for each interface

    Measured: 1 month

  3. Hours of adherence for each interface

    Measured: 1 month

  4. 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

    Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Feb 2017
  2. Study startAug 2014
  3. Primary completion31 Jan 2017
  4. Study completion30 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
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)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03063567
Sponsor's protocol ID
sryoth
Status last verified
Feb 2018
First submitted
14 Feb 2017
Last updated
27 Feb 2018
Results posted
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 30189465

Questions about this trial

What is this clinical trial studying?

A study testing CPAP interfaces in people with Obstructive Sleep Apnea of Adult, run by Singapore General Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Choice of preferred interface at the end of the one monthly trial of the 3 interfaces (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03063567, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.

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