Trial Outcomes & Findings for Ambulatory Versus Conventional Approach Diagnosing OSA (NCT NCT01828216)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

316 participants

Primary outcome timeframe

Baseline and 3 months

Results posted on

2016-03-29

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Ambulatory 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.
Overall Study STARTED	159	157
Overall Study COMPLETED	159	157
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ambulatory Versus Conventional Approach Diagnosing OSA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	In-hospital Sleep Study n=159 Participants 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.	Ambulatory Sleep Study n=157 Participants 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.	Total n=316 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 11.3 • n=5 Participants	51 years STANDARD_DEVIATION 12.9 • n=7 Participants	51.4 years STANDARD_DEVIATION 11.8 • n=5 Participants
Sex: Female, Male Female	41 Participants n=5 Participants	50 Participants n=7 Participants	91 Participants n=5 Participants
Sex: Female, Male Male	118 Participants n=5 Participants	107 Participants n=7 Participants	225 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	In-hospital CPAP Titration n=86 Participants 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.	Ambulatory CPAP Titration n=86 Participants 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.
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	-3.5 units on a scale Standard Deviation 5.0

SECONDARY outcome

Timeframe: within 24 months

Outcome measures

Outcome measures
Measure	In-hospital CPAP Titration n=69 Participants 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.	Ambulatory CPAP Titration n=62 Participants 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.
Difference in Healthcare Costs Between Ambulatory and Hospital Approach	16178 Hong Kong Dollars Standard Deviation 2288	2332 Hong Kong Dollars Standard Deviation 944

Adverse Events

In-hospital Sleep Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ambulatory Sleep Study

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

David SC Hui

Chinese University of Hong Kong

Phone: 852 2632 2211

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place