None listed
Conditions
Brief summary
The study is interventional, employing behavioural approaches and diagnostic procedures. The behavioural change aims to instil during the day (awake) and continue abdominal breathing by the participants during sleep. The study will include instructions, training and bringing abdominal muscle awareness to participants during breathing which will be mirrored with biofeedback. Secondly diagnostic procedure via Polysomnographic (PSG) sleep studies will authenticate definitive outcomes. The training on the interventions will be delivered by staff trained by Dr Peter Keller and Ms Thanusha Sothiratnam with 26 years and 14 years of experience respectively in the field of sleep diagnosis and treatment. The mode of delivery will be face to face preferably in group sessions (individually if requested by participants), employing instructions, training, as well as remote monitoring via telephone and internet.
Interventions
The study is interventional, employing behavioural approaches and diagnostic procedures. The behavioural change aims to instil during the day (awake) and continue abdominal breathing by the participants during sleep. Achievement of abdominal breathing will be attempted by instructions and training. Participant's awareness of their abdominal muscle activity will be facilitated with Biofeedback technique (ie. Thoracic and abdominal belts will be applied to the participants. Signals from these belts will be transmitted via a polysomnographic device to the computer. This will allow the patients and the researcher to view). Diagnostic procedure via polysomnographic (PSG) sleep studies will authenticate definitive outcomes. The interventions will be delivered by Dr Peter Keller, Ms Thanusha Sothiratnam with 26 years and 14 years of experience respectively in the field of sleep diagnosis and treatment, and staff trained by Dr Peter Keller and Ms Thanusha Sothiratnam. The mode of delivery will be face to face preferably in group sessions (individually if requested by participants). Automatic Positive Airway Pressure (APAP) usage at participant’s home will be monitored via a secured web-based software. For this purpose, Automatic Positive Airway Pressure (APAP) machines with built-in modem will be used. Participants will be informed that the modem will be activated to facilitate remote monitoring. After every use the data will be sent to a cloud based Microsoft Server which will enable us to monitor usage and compliance. Step 1 – Potential participants will be contacted over the phone and be invited to attend the information seminar. Step 2 – The information seminar will be conducted for small groups of 5-6 participants. The seminar will be conducted at the Clinic. The duration of the seminar will be 120 mins. During the seminar attendees will be given all pertinent information, patient information booklet and consent forms. Step 3 – Consent forms will be collected at the Clinic. The duration of this will be 10 mins per patient. Step 4 – Consent forms will be analysed, further information/documentation required (if any) will be collected and processed. Potential participants will be notified of their enrolment (successful/unsuccessful). Step 5 – Participants will be contacted and sleep study appointment will be made. Step 6 – Baseline sleep study will be carried out at the Clinic. The 10 hour duration will be overnight. Step 7 – The results of the sleep study will be discussed with the participant. Step 8 – Participants in group 2 will undergo 60 mins of training on abdominal breathing at the Clinic. Biofeedback technique will be used to mirror participant’s abdominal breathing effort, while participants in Group 1 will not undergo any new intervention via this trial. Step 9 – Participants in group 2 will be instructed to carryout 5 mins of abdominal breathing exercise, 5 times a day, over the next 2 weeks. Step 10 – 60 min biofeedback tests will be carried out on participants in group 2 to monitor abdominal breathing effort at the Clinic fortnightly. Step 11 – At the end of 55 days, a sleep study will be conducted at the Clinic to monitor the effects of participant’s abdominal breathing effort. The duration of the overnight sleep study is 10 hours. Step 12 – The results of the sleep study will be discussed with the participants. Step 10, 11 and 12 will be repeated two more times. The second sleep study will be carried out at the end of 115 days and the third sleep study will be conducted at the end of 175 days.
Sponsors
Study design
Eligibility
Inclusion criteria
People who have been medically diagnosed with mild/moderate/severe Sleep Disordered Breathing (SDB), and are on APAP therapy
Exclusion criteria
Bearing in mind the duty of care responsibilities and the health safety and welfare of the participants, those who fall under the following categories will be excluded from this study, to abide by the credo of “doing no harm” inadvertently: a. Participants below the age of 18 and above the age of 85 b. Pregnant women c. Obstructive Sleep Apnoea (OSA) with uncontrolled or untreated cardiovascular disease.