Sleep Apnea SyndromesNCT03125512
Positional Therapy Versus CPAP for Positional OSA
A study testing Night Shift positional device and continuous positive airway pressure in people with Sleep Apnea Syndromes, run by Changi General Hospital at 1 site in Singapore.
Trial summary
This is a crossover randomized controlled trial comparing a convenient positional therapy (PT) device to continuous positive airway pressure (CPAP) in the treatment of positional obstructive sleep apnea (OSA). Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Sleep Apnea Syndromes
- What is being tested?
- Night Shift positional device and continuous positive airway pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteSingapore
- Study dates
- 27 Feb 2017to 30 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 years and above
- Epworth sleepiness scale 10 to 16
- No CPAP treatment or PT treatment for past 6 months
- A diagnosis of positional OSA based on a full in-laboratory overnight polysomnography with
- Total apnea/hypopnea index (AHI) >10 /hour and non-supine AHI < 10/hour
- Supine AHI greater than or equal to two times the non-supine AHI
- At least 15 minutes of supine and non-supine sleep
Who cannot join
- Epworth sleepiness scale ≥17
- Commercial driving
- Unable or unwilling to use both treatments (CPAP and PT)
- Concurrent use of therapy for OSA such as mandibular advancement splints
- Conditions that preclude the ability to lie in a non-supine position, for example a shoulder injury
- Uncontrolled severe medical/psychiatric conditions such as severe chronic heart failure, malignancy.
- Patients with pacemaker
- Skin sensitivity around the neck and/or open wound around their neck
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing a Convenient Positional Therapy Device to CPAP for Treatment of Positional Obstructive Sleep Apnea, A Crossover Randomized Controlled Trial
This is a crossover randomized controlled trial comparing a convenient positional therapy (PT) device to continuous positive airway pressure (CPAP) in the treatment of positional obstructive sleep apnea (OSA).
Read the detailed description
This study aims to compare a convenient positional therapy (PT) device used for 8 weeks to continuous positive airway pressure (CPAP) used for 8 weeks in patients with positional obstructive sleep apnea (OSA) in a crossover randomized controlled trial.
- Conditions
- Sleep Apnea Syndromes
- Being tested
- Night Shift positional device, continuous positive airway pressure
- Keywords
- Sleep Apnea Syndromes, Positional sleep apnea, CPAP, Night Shift
- Medical subject headings
- Sleep Apnea Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Night Shift positional deviceDevice
Night Shift is a small, positional therapy device that is worn at the back of the neck using a latex free silicone rubber strap. The strap is adjustable and is secured with a magnetic clasp. When a supine position is detected, the device vibrates with increasing intensity till the subject changes to a non-supine position.
continuous positive airway pressureDevice
Automated adjusting continuous positive airway pressure
| Study group | Role | What they receive |
|---|---|---|
| Night Shift positional device | Experimental | Randomized to Night shift positional therapy first for 8 weeks, followed by CPAP for 8 weeks, with a 1 week washout period. Receives: Device: Night Shift positional device |
| Continuous positive airway pressure | Active comparator | Randomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period. Receives: Device: continuous positive airway pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epworth Sleepiness Scale ( ESS)
Difference in sleepiness ( PT minus CPAP) measured by the Epworth Sleepiness Scale ( ESS) after 8 weeks of device use
Measured: 8 weeks after the beginning of each intervention
Secondary outcomes (8)
Functional Outcomes of Sleep Questionnaire ( FOSQ)
Difference in FOSQ
Measured: 8 weeks after the beginning of each intervention
36-Item Short Form Survey (SF-36)
Difference in SF-36
Measured: 8 weeks after the beginning of each intervention
Pittsburgh Sleep Quality Index (PSQI)
Difference in PSQI
Measured: 8 weeks after the beginning of each intervention
Apnea-hypopnea Index ( AHI, events/hr)
Difference in AHI
Measured: 8 weeks after the beginning of each intervention
DASS21 questionnaire
Difference in mood symptoms ( DASS21)
Measured: 8 weeks after the beginning of each intervention
Patient adherence ( hours of device use per night)
Compare patient adherence based on device download information
Measured: 8 weeks after the beginning of each intervention
Patient preference
patient preference for treatment modality will be assessed via a questionnaire
Measured: Upon study completion at week 17
Oxygen desaturation index (3%) and lowest oxygen saturation ( %)
Oxygen indices
Measured: 8 weeks after the beginning of each intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2017
- Study start27 Feb 2017
- Primary completion10 Dec 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep Apnea SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 8-week randomized crossover trial with a 1 week washout period.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yingjuan Mok, MBBS, Principal investigator, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03125512
- Sponsor's protocol ID
- OSA_RCT
- Status last verified
- May 2019
- First submitted
- 9 Apr 2017
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Mok Y, Tan A, Hsu PP, Seow A, Chan YH, Wong HS, Poh Y, Wong KKH. Comparing treatment effects of a convenient vibratory positional device to CPAP in positional OSA: a crossover randomised controlled trial. Thorax. 2020 Apr;75(4):331-337. doi: 10.1136/thoraxjnl-2019-213547. Epub 2020 Jan 2.
PubMed 31896735
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing a Convenient Positional Therapy Device to CPAP for Treatment of Positional Obstructive Sleep Apnea, A Crossover Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03125512
- Acronym / sponsor ID
- OSA_RCT
- Conditions
- Sleep Apnea Syndromes
- Keywords
- Sleep Apnea Syndromes, Positional sleep apnea, CPAP, Night Shift
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- 10 Dec 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 24 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a crossover randomized controlled trial comparing a convenient positional therapy (PT) device to continuous positive airway pressure (CPAP) in the treatment of positional obstructive sleep apnea (OSA).
Detailed description
This study aims to compare a convenient positional therapy (PT) device used for 8 weeks to continuous positive airway pressure (CPAP) used for 8 weeks in patients with positional obstructive sleep apnea (OSA) in a crossover randomized controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 8-week randomized crossover trial with a 1 week washout period.
| Arm | Type | Receives |
|---|---|---|
| Night Shift positional device | Experimental | Device: Night Shift positional deviceRandomized to Night shift positional therapy first for 8 weeks, followed by CPAP for 8 weeks, with a 1 week washout period. |
| Continuous positive airway pressure | Active comparator | Device: continuous positive airway pressureRandomized to CPAP first for 8 weeks, followed by positional therapy for 8 weeks, with a 1 week washout period. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 21 years and above
- Epworth sleepiness scale 10 to 16
- No CPAP treatment or PT treatment for past 6 months
- A diagnosis of positional OSA based on a full in-laboratory overnight polysomnography with
Key exclusion criteria (8 listed)
- Epworth sleepiness scale ≥17
- Commercial driving
- Unable or unwilling to use both treatments (CPAP and PT)
- Concurrent use of therapy for OSA such as mandibular advancement splints
- Conditions that preclude the ability to lie in a non-supine position, for example a shoulder injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Night Shift positional deviceNight Shift is a small, positional therapy device that is worn at the back of the neck using a latex free silicone rubber strap. The strap is adjustable and is secured with a magnetic clasp. When a supine position is detected, the device vibrates with increasing intensity till the subject changes to a non-supine position. | Device | Night Shift positional device |
| continuous positive airway pressureAutomated adjusting continuous positive airway pressure | Device | Continuous positive airway pressure |
Primary outcome
Epworth Sleepiness Scale ( ESS)
Time frame: 8 weeks after the beginning of each intervention
Difference in sleepiness ( PT minus CPAP) measured by the Epworth Sleepiness Scale ( ESS) after 8 weeks of device use
8 secondary outcomes
Functional Outcomes of Sleep Questionnaire ( FOSQ)
Time frame: 8 weeks after the beginning of each intervention
36-Item Short Form Survey (SF-36)
Time frame: 8 weeks after the beginning of each intervention
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 8 weeks after the beginning of each intervention
Apnea-hypopnea Index ( AHI, events/hr)
Time frame: 8 weeks after the beginning of each intervention
DASS21 questionnaire
Time frame: 8 weeks after the beginning of each intervention
Patient adherence ( hours of device use per night)
Time frame: 8 weeks after the beginning of each intervention
Patient preference
Time frame: Upon study completion at week 17
Oxygen desaturation index (3%) and lowest oxygen saturation ( %)
Time frame: 8 weeks after the beginning of each intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Derived from this study: PubMed 31896735Mok Y, Tan A, Hsu PP, Seow A, Chan YH, Wong HS, Poh Y, Wong KKH. Comparing treatment effects of a convenient vibratory positional device to CPAP in positional OSA: a crossover randomised controlled trial. Thorax. 2020 Apr;75(4):331-337. doi: 10.1136/thoraxjnl-2019-213547. Epub 2020 Jan 2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yingjuan Mok, MBBS principal investigator
Changi General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Night Shift positional device and continuous positive airway pressure in people with Sleep Apnea Syndromes, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epworth Sleepiness Scale ( ESS) (time frame: 8 weeks after the beginning of each intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03125512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2019.