Investigation of Predictive Indices to Objectively Guide Choice of CPAP Interface

NCT03063567 | Completed

• 1 other identifier: sryoth
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

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

Conditions

Obstructive Sleep Apnea of Adult

Outcome Measures

Primary Outcomes (1)

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

  6 month

Secondary Outcomes (4)

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

  1 month

• Amount of leak for each interface

  1 month

• Hours of adherence for each interface

  1 month

• Compliance with the chosen interface at 6 month follow-up

  6 month

Study Arms (3)

one month trial of Nasal Mask

OTHER

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.

Device: CPAP interfaces

One month trial of Oronasal mask

OTHER

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.

Device: CPAP interfaces

One month trial of Nasal pillows

OTHER

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.

Device: CPAP interfaces

Interventions

CPAP interfaces DEVICE

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.

One month trial of Nasal pillows; One month trial of Oronasal mask; one month trial of Nasal Mask

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Singapore General Hospital: lead

Related Publications (1)

• 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.

  PMID: 30189465 DERIVED

Study Officials

• Rui Ya Soh

  Singhealth Foundation

  PRINCIPAL INVESTIGATOR

• Thun How Ong

  Singhealth Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 14, 2017
• First Posted: February 24, 2017
• Study Start: August 1, 2014
• Primary Completion: January 31, 2017
• Study Completion: March 30, 2017
• Last Updated: February 27, 2018

Record last verified: 2018-02