None listed
Conditions
Brief summary
The study is interventional, employing devices, behavioural approaches and diagnostic procedures. The behavioural change aims to instil and continue abdominal breathing by the participants during sleep. Firstly this will be attempted by instructions, training, participant's abdominal muscle awareness during breathing, This will be assisted with Biofeedback. Secondly supporting activity via EMS and APAP devices may need to be utilised. Thirdly diagnostic procedure via Polysomnographic (PSG) sleep studies will authenticate definitive outcomes. The interventions will delivered by themselves and 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 and devices, as well as remote monitoring via telephone and internet.
Interventions
The study is interventional, employing devices, behavioural approaches and diagnostic procedures. The behavioural change aims to instil and continue abdominal breathing by the participants during sleep. Firstly this will be attempted by instructions, training and participant's awareness of their abdominal muscle activity. This will be facilitated with Biofeedback. Secondly supporting activity via Electrical Muscle Stimulator (EMS) and Automatic Positive Airway Pressure (APAP) devices may need to be utilised (where ever APAP is used, it will be used with a pressure setting of 4-20 cmH2O with humidification). Thirdly 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), employing instructions, training and devices. Abdominal breathing practice undertaken at participant's own home will be monitored via calls/SMS. APAP usage at participant’s home will be monitored via a secured web-based software. For this purpose, 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. Duration 6 weeks approx (Step 4 mentioned below will be undertaken concurrently, while other steps will be sequential): Step 1 - Introductory information session - Day 1 - 90minutes - in the Clinic Step 2 - Overnight PSG Sleep Study to establish base line - Night 1 – 8 to 10 hours - in the Clinic Step 3 - Abdominal breathing training with Biofeedback - Day 2 - 1 hour - in the Clinic Step 4 - Abdominal breathing practice - Day 2 to Day 17 - 5 X 5 minutes sessions per day for 2 weeks - in the participants' own home Step 5 - Muscle Memory Retention (MMR) establishment monitoring via Biofeedback - Day 18 - 1 hour - in the Clinic along with 5 X 5 minutes sessions per day till their next PSG - in the participants' own home Step 6 - If MMR is established in point 5, Abdominal breathing practice will be continued till their next PSG - Day 19 to Day 25 - 5 X 5 minutes sessions per day till their next PSG - in the participants' own home Step 7 - If MMR is not established in point 5, EMS and APAP will be introduced for assistance to embrace abdominal breathing - Day 19 - 2 hours - in the Clinic along with 5 X 5 minutes sessions per day till their next PSG - in the participants' own home Step 8 - If MMR is established in point 7, Abdominal breathing practice will be continued till their next PSG - Day 20 to Day 26 - 5 X 5 minutes sessions per day till their next PSG - in the participants' own home Step 9 - If MMR is not established in point 7, further assistance (additional Biofeedback sessions with EMS, +/- APAP) will be offered - Day 20 to Day 26 - 5 X 5 minutes sessions per day till their next PSG - in the participants' own home Step 10 - Overnight PSG Sleep Study will be carried out to see if MMR can be retained during sleep - Day 20 to Day 26 - Night 2 – 8 to 10 hours - in the Clinic Step 11 - If MMR is established in point 10, Abdominal breathing practice will be continued between their long term Biofeedback monitoring sessions and Overnight PSG Sleep Study - Day 27 to Day 47 - 30 minute (Biofeedback monitoring sessions) - in the Clinic and Night 3 to Night 8 – 8 to 10 hours (Overnight PSG Sleep Study) - in the Clinic along with 5 X 5 minutes sessions per day till the end of the 5 yr study period - in the participants' own home Step 12 - If MMR is not established in point 10, participants will have full PSG with EMS - Night 3 – 8 to 10 hours - in the Clinic along with 5 X 5 minutes sessions per day till their next PSG - in the participants' own home Step 13 - 4 to 5 fortnightly sessions with EMS and Biofeedback till MMR is confirmed with PSG - Day 27 to Day 32 - 30 minute - in the Clinic along with 5 X 5 minutes sessions per day till their next PSG - in the participants' own home Step 14 - In point 13, if MMR is not established, Participants will be asked to use APAP in their own homes - compliance will be monitored remotely - Night 4 to Night 34 - Greater than 4 hours/night - in the participants' own home along with 5 X 5 minutes sessions per day till their next PSG - in the participants' own home Step 15 - Full PSG with APAP after the 4 weeks - Night 35 – 8 to 10 hours - in the Clinic Step 16 - If desirable, APAP will be used in conjunction with EMS to try and reduce APAP pressure and achieve compliance - Night 36 - 8 to 10 hours - in the Clinic Step 17 - PSG and Biofeedback sessions will be carried out in the Clinic to monitor compliance throughout the trial period Step 18 - If the compliance is below medically accepted standards, participants will be offered to join the stage at which they demonstrated MMR and continue the process from there Step 19 - At all stages, participants' GPs and Specialists will be apprised of their progress
Sponsors
Study design
Eligibility
Inclusion criteria
1. People who have experienced disturbed sleep patterns, 2. People who have been witnessed to have apnoeic episodes, 3. People who have been medically diagnosed with mild/moderate/severe Sleep Disordered Breathing (SDB), on treatment but not compliant partially/fully.
Exclusion criteria
Exclusion criteria will be PPs with pacemaker, implantable cardioverter defibrillator (ICD), on dialysis, pregnancy or lactation, current participation in another clinical trial, medication usage that could influence respiration or sleep (eg, regular use of sedatives, heavy alcohol consumption), OSA with uncontrolled or untreated cardiovascular disease, severe somatic or psychiatric disorders those who were tested positive for narcolepsy/cataplexy, idiopathic somnolence, severe somatic or psychiatric disorders, children and young people, People highly dependent on medical care, people who may be involved in illegal activities, people with cognitive impairment and intellectual disability or a mental illness.