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Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea. (IPOSAT)

Primary Purpose

Obstructive Sleep Apnea

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Behaviour change Intervention Based on Health Action Process Approach Model
Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard
Sponsored by
Queen Mary University of London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea

Eligibility Criteria

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

Inclusion Criteria:

  • Adult (≥ 40 years old)
  • Confirmed diagnosis of OSA (AHI ≥ 5)
  • Referred for MAA therapy
  • Must be able to understand, read and write English; with the assistance of a translator

Exclusion Criteria:

  • Insufficient teeth for MAA fabrication
  • Poor dental and/or periodontal health
  • Symptomatic Temporomandibular Disorder (TMD)
  • Previously used an MAA
  • Patients with Epilepsy

Sites / Locations

  • Royal London Dental HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention Care Group

Standardized Care Group

Arm Description

The Intervention care group will receive the Mandibular Advancement Appliance (MAA) or the anti-snoring mouthguard. Additionally, they will also receive special support in the form of behaviour change interventions. The behavior change interventions consist of motivational interviewing, will be shown a video highlighting the negative consequences of sleep apnoea. Booster calls at week 3,6, 18 and 12 for verbal encouragement and to resolve any technical problems with the device. Participants will be asked to complete questionnaires regarding their personality, socio-economic status, social support and quality of sleep and life.

The standardized care group will only receive the Mandibular Advancement Appliance (MAA) or the anti-snoring mouthguard along with routine care and will be called for follow up at 3rd and 6th month of treatment to assess their use and to resolve any technical problems with the device. Participants will be asked to complete questionnaires regarding their personality, socio-economic status, social support and quality of sleep and life at the initial visit and subsequent follow-up.

Outcomes

Primary Outcome Measures

Adherence- the number of hours the patient uses the MAA or anti-snoring mouth guard every night
the number of the hours the patient uses the appliance every night will be measured both objectively and subjectively at 3 and 6 months to assess the effectiveness of the interventions in enhancing adherence to MAA.
Adherence-the number of hours the patient uses the MAA or anti-snoring mouth guard
the number of the hours the patient uses the appliance every night will be measured both objectively and subjectively at 3 and 6 months to assess the effectiveness of the interventions in enhancing adherence to MAA.

Secondary Outcome Measures

Self-efficacy, risk perception, outcome expectancy
Self-efficacy, risk perception, outcome expectancy will be measured using the Self-efficacy Measure for Sleep Apnoea (SEMSA) questionnaire
Socio-economic status
Socio-economic Status questionnaire based on National Statistics Socio-Economic Classification.
Social support
Social Support Questionnaire
Sleep Quality
Sleep Quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Sleepiness Score: How likely is the participant to fall asleep in certain situations?
Epworth Sleepiness Scale Questionnaire will be used to assess the sleepiness score.
Health related Quality of Life
EQ-5D questionnaire will be used to measure the quality of life.

Full Information

First Posted
September 13, 2019
Last Updated
May 18, 2023
Sponsor
Queen Mary University of London
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1. Study Identification

Unique Protocol Identification Number
NCT04092660
Brief Title
Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.
Acronym
IPOSAT
Official Title
Intervention to Enhance Adherence to Mandibular Advancement Appliance in Patients With Obstructive Sleep Apnoea: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 6, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Queen Mary University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
Obstructive Sleep Apnoea (OSA) is a sleep-related breathing disorder that is characterized by the repeated collapse of the upper airway during sleep, resulting in sleep deprivation. Mandibular Advancement Appliances (MAA) or Oral Appliances (OA) is prescribed for the patients with OSA and they have been shown to be effective. However, they rely entirely on the patient's acceptance and use. The aim of this study is to assess whether interventions- additional support approaches, will help patients use their MAA more as compared to those who receive routine care. The investigators also will try and identify factors that help us to understand why some patients choose to wear the MAA more than others. Adults (≥40 years) with a confirmed diagnosis of OSA (apnoea-hypopnoea index >5) and referred for MAA therapy will be included in this study. It is a multicentre study comprised of recruiting patients from secondary care. Patients will be provided with information in relation to the study and written informed consent obtained at their subsequent appointment for placement of MAA. Patients will be randomly assigned to Intervention Care (IC) and Standardised care (SC). Patients will also be provided with a sleep diary to subjectively record their hours of sleep and usage of MAA and an objective adherence record from the micro-sensor included in their MAA design. Data indicating adherence will be collected and evaluated, both subjectively at 3- (T2) and 6-months (T3) and objectively by downloading the data stored within a micro-sensor placed in the MAA device. At the end of the follow-up, the investigators also plan to undertake a qualitative one-to-one interview with patients compliant (users) and non-compliant (non-users) to identify their views of what helps and/or prevents their adherence.
Detailed Description
The present study aims to assess whether special support approaches i.e. Interventions influence patients with Obstructive sleep apnoea (OSA), to use the Mandibular Advancement Appliance (MAA) or the anti-snoring mouth guard, more as compared to those who receive standard care. Factors such as mood, anxiety, stress, depression, socioeconomic status, and social support play an important role in the ability of the patients to make decisions about using the appliance. Thus, the investigators also aim to explore the potential role these factors play in the decision-making process to help future patients make most of their treatments. Patients meeting the selection criteria will be provided with a patient information leaflet, explaining the whole study. Interested patients will be asked to sign the Informed Consent, after which they will be randomly assigned into two groups- Intervention Care group (IC) and Standardized Care group (SCG). Patients will be provided with a sleep diary to record their hours of sleep and usage of MAA, which will give a subjective record of the adherence (duration of usage of MAA) and an objective record of the adherence will be collected from a sensor present in the MAA. At Initial Screening, the patient's age, gender, body mass index (BMI) and neck circumference will be recorded. Patients in the IC group will receive a Health Pamphlet about OSA, specially designed for this study. The IC group's knowledge of OSA will be assessed along with their partner's. Patients in the IC group will be shown a 10 min video highlighting the negative impact of OSA. While patients in the SC group will only be provided with a pamphlet about OSA and MAA as per standard routine care. Patients of both the group will be asked to complete questionnaires regarding their personality, socioeconomic status, social support and quality of sleep and life. Along the course of the treatment, patients in the IC group will be contacted by telephone at 3, 6, 18, and 21 weeks into the treatment to solve any technical problems with the appliance and for verbal encouragement. Both IC and SC groups will be called for follow-up at 3 and 6 months into the treatment. Data indicating the hours of usage of the MAA will be collected at 3 and 6 months to assess whether patients in the IC group wore the appliance for more hours as compared to those who are in the SC group. Patients will also be required to complete questionnaires at follow-up appointments. Data from the questionnaires will be analyzed to identify the factors influencing patients adherence to MAA. At the end of follow-up, one-to-one interviews will be conducted with both (n=5-10) compliant (users) and non-compliant (non-users) patients. It will comprise of questions, which will address the following topics: Patient's awareness of risks and benefits of OSA Barriers and Facilitators of MAA therapy The interviews will be conducted face-to-face and will be recorded using an audio recorder device and transcribed by a third party, Essential Secretary LTD.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Multicentre Randomized Control Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Care Group
Arm Type
Experimental
Arm Description
The Intervention care group will receive the Mandibular Advancement Appliance (MAA) or the anti-snoring mouthguard. Additionally, they will also receive special support in the form of behaviour change interventions. The behavior change interventions consist of motivational interviewing, will be shown a video highlighting the negative consequences of sleep apnoea. Booster calls at week 3,6, 18 and 12 for verbal encouragement and to resolve any technical problems with the device. Participants will be asked to complete questionnaires regarding their personality, socio-economic status, social support and quality of sleep and life.
Arm Title
Standardized Care Group
Arm Type
Active Comparator
Arm Description
The standardized care group will only receive the Mandibular Advancement Appliance (MAA) or the anti-snoring mouthguard along with routine care and will be called for follow up at 3rd and 6th month of treatment to assess their use and to resolve any technical problems with the device. Participants will be asked to complete questionnaires regarding their personality, socio-economic status, social support and quality of sleep and life at the initial visit and subsequent follow-up.
Intervention Type
Behavioral
Intervention Name(s)
Behaviour change Intervention Based on Health Action Process Approach Model
Intervention Description
The Behaviour change intervention based on the Health Action Process Approach model entails delivering interventions in a staged manner. Following are the intervention that will be delivered along with the time point of the delivery. Health Pamphlet at the initial screening Sleep Apnoea video highlighting the negative consequences at the day of the fitting of the appliance Counseling involving motivational interviewing for both the participant and the participant's partner at the day of fitting of the appliance and follow up visits. Booster phone calls in between the follow-up visits
Intervention Type
Device
Intervention Name(s)
Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard
Intervention Description
Patients with mild-to-moderate sleep apnoea are treated with Mandibular Advancement Appliances [MAA] also known as Anti-snoring mouth guards or Oral appliances. These are best made to fit and use the teeth to hold them in place during sleep. They work by moving (in a gradual fashion) the bottom jaw forward, opening the airway at the back of the throat. Both the arms- Intervention arm and Standardized arm will be given the anti-snoring mouth guard. The usage of the device will be measured subjectively by providing a sleep diary to the participants to record the hour of the usage and objectively by downloading the data from a micro sensor chip embedded in the device.
Primary Outcome Measure Information:
Title
Adherence- the number of hours the patient uses the MAA or anti-snoring mouth guard every night
Description
the number of the hours the patient uses the appliance every night will be measured both objectively and subjectively at 3 and 6 months to assess the effectiveness of the interventions in enhancing adherence to MAA.
Time Frame
3 months
Title
Adherence-the number of hours the patient uses the MAA or anti-snoring mouth guard
Description
the number of the hours the patient uses the appliance every night will be measured both objectively and subjectively at 3 and 6 months to assess the effectiveness of the interventions in enhancing adherence to MAA.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Self-efficacy, risk perception, outcome expectancy
Description
Self-efficacy, risk perception, outcome expectancy will be measured using the Self-efficacy Measure for Sleep Apnoea (SEMSA) questionnaire
Time Frame
Initial screening, 3 and 6 month
Title
Socio-economic status
Description
Socio-economic Status questionnaire based on National Statistics Socio-Economic Classification.
Time Frame
Initial Screening
Title
Social support
Description
Social Support Questionnaire
Time Frame
Initial Screening
Title
Sleep Quality
Description
Sleep Quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire
Time Frame
Initial Screening and 6 month
Title
Sleepiness Score: How likely is the participant to fall asleep in certain situations?
Description
Epworth Sleepiness Scale Questionnaire will be used to assess the sleepiness score.
Time Frame
Initial Screening and 6 month
Title
Health related Quality of Life
Description
EQ-5D questionnaire will be used to measure the quality of life.
Time Frame
Initial Screening and 6 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult (≥ 40 years old) Confirmed diagnosis of OSA (AHI ≥ 5) Referred for MAA therapy Must be able to understand, read and write English; with the assistance of a translator Exclusion Criteria: Insufficient teeth for MAA fabrication Poor dental and/or periodontal health Symptomatic Temporomandibular Disorder (TMD) Previously used an MAA Patients with Epilepsy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ama Johal
Phone
0207 377 7686
Email
a.s.johal@qmul.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Harishri Tallamraju
Phone
07788128535
Email
h.tallamraju@qmul.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ama Johal
Organizational Affiliation
Queen Mary University of London
Official's Role
Study Chair
Facility Information:
Facility Name
Royal London Dental Hospital
City
London
ZIP/Postal Code
E1 2AD
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ama Johal
Phone
138651
Email
a.s.johal@qmul.ac.uk
First Name & Middle Initial & Last Name & Degree
Harishri Tallamraju
Phone
07788128535
Email
h.tallamraju@qmul.ac.uk

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34645490
Citation
Tallamraju H, Newton JT, Fleming PS, Johal A. Intervention to enhance adherence to mandibular advancement appliance in patients with obstructive sleep apnoea: study protocol for a randomised clinical trial. Trials. 2021 Oct 13;22(1):699. doi: 10.1186/s13063-021-05582-1.
Results Reference
derived

Learn more about this trial

Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.

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