None listed
Conditions
Brief summary
Obstructive Sleep Apnea (OSA) is a highly prevalent condition that can lead to significant cardiovascular and metabolic complications if left untreated. While Continuous Positive Airway Pressure (CPAP) therapy is highly effective, long-term patient adherence remains a significant challenge, with many patients abandoning therapy within the first month. This study is a prospective non-randomized controlled trial designed to evaluate the impact of an intensive telemonitoring program on CPAP adherence over a 12-month period. Participants with moderate to severe OSA will be allocated into two groups:Intervention Group: Participants receive standard CPAP acclimatization plus intensive daily telemonitoring. Staff will proactively contact patients who show low usage to provide motivational coaching and troubleshooting. Control Group: Participants receive standard CPAP acclimatization and follow-up (usual care) through the public health system in Canberra.The primary objective is to determine if intensive telemonitoring improves the proportion of patients achieving clinical adherence at 12-months. Secondary objectives include assessing improvements in sleep-related functional status, as well as conducting a cost-benefit analysis of the telemonitoring intervention compared to usual care in the Australian Capital Territory.
Interventions
All patients will undergo CPAP acclimatisation delivered through Air Liquide Healthcare (ALH), but those in the telemonitoring arm will also have daily telemonitoring reviews in addition to ALH’s usual acclimatisation protocol. Once successfully acclimatized and compliant with a usage of equal or greater from 4hrs a night for a minimum of 70% of nights over a 4-week period, participants will then go on to either continue with intensive telemonitoring for the remainder of the year in addition to seeing their sleep physician, or will go back to their sleep physician to receive usual care. Both arms Participants arm use a commercial Philips DreamStation AutoCPAP machine nightly during sleep to treat OSA. As for the intensive telemonitoring arm, telemonitoring involves staff daily reviewing data (adherence, leak, and efficacy) with a customer service team (specifically addressed as "care team") who reach out patients essentially through phone calls (SMS when not available) to support the patient. When the care team is unable to solve the issue remotely through phone calls, the patient may be referred back to the CPAP consultants at the CPAP clinic, prior to escalation to the referring Prescriber. All interactions with the patients are tracked in 'minutes' as to integrate the cost of care in the review of the value based healthcare approach. Here below are the therapy data criteria leading to intervention by the care team: 1- Excessive mask leak: over 24 L per min on two consecutive days. 2- Low therapy usage: Average daily usage falls below 4-hours over seven consecutive days. 3- Inadequate treatment efficacy: An Apnea-Hypopnea Index or AHI over 8 events per hour on two consecutive days. 4- No usage: Zero recorded usage on two consecutive days. 5- Data transmission issues: No data transmitted from the device on two consecutive days.
Sponsors
Study design
Eligibility
Inclusion criteria
I. CPAP-naïve participants II. over 16 years of age. III. Severe OSA (AHI equal or greater to 30). or Moderate OSA (AHI equal or greater to 15) and presenting one of the following six symptoms: 1-Excessive Day time sleepiness with ESS equal or greater to 10; 2-Regular loud snoring; 3-Waking choking / gasping; 4-Regular complains of dry mouth; 5-Complains of fragmented sleep; 6- Regular Morning headaches on waking. and IV. OSA diagnosed via level 1 or level 2 polysomnography within one year of enrollment, performed through a certified sleep laboratory.
Exclusion criteria
Patient under 16 years of age; Significant hypoventilation or central apnoeas on polysomnography; Previous CPAP use; Inability to speak or read English; Terminal illness with a life expectancy of less than one year; Physical or cognitive contraindications to using CPAP therapy.