OSA
Conditions
Brief summary
Very few studies have examined different models of care involving initial ambulatory home-based diagnosis in diagnosing obstructive sleep apnea (OSA), identifying patients who benefit from continuous positive airway pressure (CPAP), and reducing the need for polysomnography (PSG). This study aims to assess the role of an ambulatory approach with home diagnostic sleep study. We hypothesize that the ambulatory approach is as good as the conventional approach in managing OSA in terms of improvement of clinical outcome but the former approach will lead to substantial cost savings.
Detailed description
We conducted a prospective, randomized, controlled continuous positive airway pressure (CPAP) parallel study on new referrals to the Respiratory Clinic, Prince of Wales Hospital, with suspected obstructive sleep apnea (OSAS). OSAS was defined by apnea-hypopnea index(AHI) 5/hr or more of sleep plus excessive daytime sleepiness or two of the following symptoms: choking or gasping during sleep, recurrent awakenings from sleep, unrefreshed sleep, daytime fatigue, and impaired concentration. All patients with suspected OSAS underwent assessment at the clinic with the Epworth sleepiness score(ESS) and symptoms evaluation. Patients who had ESS score\>9 or at least two OSAS symptoms as described above were invited to join the study. They were randomized into either group A)home-based management approach or group B)hospital-based management approach by a random table by a third party not involved in the trial.
Interventions
DEVICEHome sleep study
The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events
DEVICEconventional polysomnography
conventional type I sleep study according to international guidelines
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* symptoms of OSA with home sleep study AHI \>= 15/hr.
Exclusion criteria
* unstable cardiovascular diseases (e.g. recent unstable angina, myocardial infarction, stroke or transient ischemic attack within the previous 6 months or severe left ventricular failure) * neuromuscular disease affecting or potentially affecting respiratory muscles * moderate to severe respiratory disease (i.e. breathlessness affecting activities of daily living) or documented hypoxemia or awake oxygen saturation of \<92% * psychiatric disease that limits the ability to give informed consent or complete the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment | Baseline and 3 months | The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought. |
Secondary
| Measure | Time frame |
|---|---|
| Difference in Healthcare Costs Between Ambulatory and Hospital Approach | within 24 months |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| In-hospital Sleep Study Conventional polysomnography will be performed as in-patient at Prince of Wales Hospital for every subject in this group, recording electroencephalogram, electro-oculogram, submental electromyogram, bilateral anterior tibial electromyogram, electrocardiogram, chest & abdominal wall movement by inductance plethysmography, airflow measured by a nasal pressure transducer & supplemented by oronasal airflow thermistor, & finger pulse oximetry. | 159 |
| Ambulatory Sleep Study home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events. | 157 |
| Total | 316 |
Baseline characteristics
| Characteristic | In-hospital Sleep Study | Ambulatory Sleep Study | Total |
|---|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 11.3 | 51 years STANDARD_DEVIATION 12.9 | 51.4 years STANDARD_DEVIATION 11.8 |
| Sex: Female, Male Female | 41 Participants | 50 Participants | 91 Participants |
| Sex: Female, Male Male | 118 Participants | 107 Participants | 225 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 159 | 0 / 157 |
| serious Total, serious adverse events | 0 / 159 | 0 / 157 |
Outcome results
Primary
Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment
The Epworth Sleepiness Scale (ESS) is a scale intended to measure daytime sleepiness that is measured by use of a very short questionnaire. The questionnaire asks the subject to rate his or her probability of falling asleep on a scale of increasing probability from 0 to 3 for eight different situations that most people engage in during their daily lives, though not necessarily every day. The scores for the eight questions are added together to obtain a single number. A number in the 0-9 range is considered to be normal while a number in the 10-24 range indicates that expert medical advice should be sought.
Time frame: Baseline and 3 months
Population: Following detection of apnea-hypopnea index (AHI) of 15 events per hour or more by home sleep study or polysomnography, patients received CPAP therapy for 3 months after an overnight autoCPAP titration at in-hospital or ambulatory home setting.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-hospital CPAP Titration | Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment | -2.2 units on a scale | Standard Deviation 5.2 |
| Ambulatory CPAP Titration | Change in Epworth Sleepiness Score (ESS) Before and After 3 Months of Continuous Positive Airway Pressure (CPAP) Treatment | -3.5 units on a scale | Standard Deviation 5 |
Secondary
Difference in Healthcare Costs Between Ambulatory and Hospital Approach
Time frame: within 24 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| In-hospital CPAP Titration | Difference in Healthcare Costs Between Ambulatory and Hospital Approach | 16178 Hong Kong Dollars | Standard Deviation 2288 |
| Ambulatory CPAP Titration | Difference in Healthcare Costs Between Ambulatory and Hospital Approach | 2332 Hong Kong Dollars | Standard Deviation 944 |