Obstructive Sleep Apnea SyndromeNCT01715194
Telemedicine to Enhance Adherence to CPAP Therapy in Patients With OSAS
A study testing Telemedicine intervention in people with Obstructive Sleep Apnea Syndrome, run by Otto D. Schoch at 1 site in Switzerland.
Trial summary
We hypothesize that the use of telemedicine combined with support interventions by short messages, telephone calls and ambulatory visits to control CPAP treatment during the first month improves adherence and reduces unresolved side effects of therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea Syndrome
- What is being tested?
- Telemedicine intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of >5/h in polysomnography (PSG) consenting to start longterm CPAP treatment.
Who cannot join
- Age <18 years
- Unable to communicate in German, English, French or Italian
- Alcohol consumption > 4 units >4 times a week
- Acute manifestation of psychiatric diseases
- Life expectancy of < 6 months for any reason
- Surgical obesity treatment planned within the next 6 months
- Predominantly Central sleep apnea and cheyne stokes respiration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telemedicine to Enhance Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome; a Randomized Placebo-controlled Prospective Study
We hypothesize that the use of telemedicine combined with support interventions by short messages, telephone calls and ambulatory visits to control CPAP treatment during the first month improves adherence and reduces unresolved side effects of therapy.
The primary objective of an OSAS treatment program is to successfully implement indicated CPAP in the highest possible proportion of patients in order to lower the proportion of untreated OSAS in the population. On an individual basis, it has been shown that a longer duration of CPAP use is associated with better outcomes in terms of daytime functioning and in the control of metabolic and blood pressure effects of CPAP. For our study, we have therefore decided to use 2 co-primary endpoints, taking into account both aspects of adherence mentioned. Cardiovascular complications are a major concern in OSAS patients. Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk. We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of treatment.
- Conditions
- Obstructive Sleep Apnea Syndrome
- Being tested
- Telemedicine intervention
- Keywords
- OSAS, CPAP, Adherence, Telemedicine
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine interventionDevice
Also called ResMed Telemedicine S9 Wireless-Modul
Patients undergoing telemedicine intervention
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine intervention | Active comparator | In the telemedicine intervention arm, a telemetry device is instructed and attached to the CPAP. Patients are instructed to use CPAP every night. Data of the CPAP are downloaded to the internet once daily. On week days, a nurse is checking the downloaded data three times per week. The nurse contacts the patient if
1. CPAP was used <4h/ night for 2 consecutive night
2. the median leakage was above 0.4 L/sec on 2 consecutive nights The nurse informs the patient of the problem observed, asks for explanations and gives advice on possibilities to solve the problem. The common problems and the respective solutions are discussed according to the ELF facts sheet (Dry mouth/throat, nasal congestion, skin irritation, conjunctivitis, headache, loss of benefits, appendix 1). The patient is encouraged to use CPAP every night. In the case of regular use and acceptable leakage, a congratulatory message is sent to the patient via sms or e-mail (for procedural rules, see appendix 4). Receives: Device: Telemedicine intervention |
| Control (without telemedicine) | No intervention | In the control arm, no device is attached to the CPAP machine, but data stored in the CPAP machine are collected at the follow-up visit after 1 month of CPAP use. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of nights with CPAP use (defined as ≥1h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months
Measured: at 6 months
Secondary outcomes (1)
Average nightly use of CPAP during the first 6 months of treatment (minutes per night including nights of no-use of CPAP since day 1)
Measured: at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep Apnea SyndromeStudies 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Otto D. Schoch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Otto D. Schoch, Cantonal Hospital of St. Gallen
- Investigators
- Martin Brutsche, MD, PhD, Study director, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715194
- Sponsor's protocol ID
- EKSG 12/076
- Status last verified
- Jul 2016
- First submitted
- 10 Oct 2012
- Last updated
- 26 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.
PubMed 20880872Lankford DA. Wireless CPAP patient monitoring: accuracy study. Telemed J E Health. 2004 Summer;10(2):162-9. doi: 10.1089/tmj.2004.10.162.
PubMed 15319046Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, Leeds W. Telehealth services to improve nonadherence: A placebo-controlled study. Telemed J E Health. 2006 Jun;12(3):289-96. doi: 10.1089/tmj.2006.12.289.
PubMed 16796496Stepnowsky CJ, Palau JJ, Marler MR, Gifford AL. Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea. J Med Internet Res. 2007 May 17;9(2):e14. doi: 10.2196/jmir.9.2.e14.
PubMed 17513285Kwiatkowska M, Ayas N. Can telemedicine improve CPAP adherence? Thorax. 2010 Dec;65(12):1035-6. doi: 10.1136/thx.2010.140897. Epub 2010 Oct 26. No abstract available.
PubMed 20978030Schoch OD, Baty F, Boesch M, Benz G, Niedermann J, Brutsche MH. Telemedicine for Continuous Positive Airway Pressure in Sleep Apnea. A Randomized, Controlled Study. Ann Am Thorac Soc. 2019 Dec;16(12):1550-1557. doi: 10.1513/AnnalsATS.201901-013OC.
PubMed 31310575
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telemedicine to Enhance Adherence to Continuous Positive Airway Pressure Therapy in Patients With Obstructive Sleep Apnea Syndrome; a Randomized Placebo-controlled Prospective Study
- ClinicalTrials.gov ID
- NCT01715194
- Acronym / sponsor ID
- EKSG 12/076
- Conditions
- Obstructive Sleep Apnea Syndrome
- Keywords
- OSAS, CPAP, Adherence, Telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Otto D. SchochUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 26 Oct 2012 (estimated)
- 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.
We hypothesize that the use of telemedicine combined with support interventions by short messages, telephone calls and ambulatory visits to control CPAP treatment during the first month improves adherence and reduces unresolved side effects of therapy.
The primary objective of an OSAS treatment program is to successfully implement indicated CPAP in the highest possible proportion of patients in order to lower the proportion of untreated OSAS in the population. On an individual basis, it has been shown that a longer duration of CPAP use is associated with better outcomes in terms of daytime functioning and in the control of metabolic and blood pressure effects of CPAP. For our study, we have therefore decided to use 2 co-primary endpoints, taking into account both aspects of adherence mentioned. Cardiovascular complications are a major concern in OSAS patients. Effective CPAP treatment has been shown to reduce surrogate measures of cardiovascular risk. We hypothesize that intensified efforts for CPAP adherence with telemedicine has a positive impact on a number of surrogate measures of the cardiovascular risk at 1 and 6 months of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine intervention | Active comparator | Device: Telemedicine interventionIn the telemedicine intervention arm, a telemetry device is instructed and attached to the CPAP. Patients are instructed to use CPAP every night. Data of the CPAP are downloaded to the internet once daily. On week days, a nurse is checking the downloaded data three times per week. The nurse contacts the patient if 1. CPAP was used <4h/ night for 2 consecutive night 2. the median leakage was above 0.4 L/sec on 2 consecutive nights The nurse informs the patient of the problem observed, asks for explanations and gives advice on possibilities to solve the problem. The common problems and the respective solutions are discussed according to the ELF facts sheet (Dry mouth/throat, nasal congestion, skin irritation, conjunctivitis, headache, loss of benefits, appendix 1). The patient is encouraged to use CPAP every night. In the case of regular use and acceptable leakage, a congratulatory message is sent to the patient via sms or e-mail (for procedural rules, see appendix 4). |
| Control (without telemedicine) | No intervention | –In the control arm, no device is attached to the CPAP machine, but data stored in the CPAP machine are collected at the follow-up visit after 1 month of CPAP use. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Symptomatic OSAS patients with an AHI and an oxygen desaturation index (ODI) of >5/h in polysomnography (PSG) consenting to start longterm CPAP treatment.
Key exclusion criteria (7 listed)
- Age <18 years
- Unable to communicate in German, English, French or Italian
- Alcohol consumption > 4 units >4 times a week
- Acute manifestation of psychiatric diseases
- Life expectancy of < 6 months for any reason
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 |
|---|---|---|
| Telemedicine interventionAlso: ResMed Telemedicine S9 Wireless-ModulPatients undergoing telemedicine intervention | Device | Telemedicine intervention |
Primary outcome
Proportion of nights with CPAP use (defined as ≥1h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months
Time frame: at 6 months
1 secondary outcome
Average nightly use of CPAP during the first 6 months of treatment (minutes per night including nights of no-use of CPAP since day 1)
Time frame: at 6 months
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 26 Jul 2016.
- Background: PubMed 20880872Sparrow D, Aloia M, Demolles DA, Gottlieb DJ. A telemedicine intervention to improve adherence to continuous positive airway pressure: a randomised controlled trial. Thorax. 2010 Dec;65(12):1061-6. doi: 10.1136/thx.2009.133215. Epub 2010 Sep 29.
- Background: PubMed 15319046Lankford DA. Wireless CPAP patient monitoring: accuracy study. Telemed J E Health. 2004 Summer;10(2):162-9. doi: 10.1089/tmj.2004.10.162.
- Background: PubMed 16796496Smith CE, Dauz ER, Clements F, Puno FN, Cook D, Doolittle G, Leeds W. Telehealth services to improve nonadherence: A placebo-controlled study. Telemed J E Health. 2006 Jun;12(3):289-96. doi: 10.1089/tmj.2006.12.289.
- Background: PubMed 17513285Stepnowsky CJ, Palau JJ, Marler MR, Gifford AL. Pilot randomized trial of the effect of wireless telemonitoring on compliance and treatment efficacy in obstructive sleep apnea. J Med Internet Res. 2007 May 17;9(2):e14. doi: 10.2196/jmir.9.2.e14.
- Background: PubMed 20978030Kwiatkowska M, Ayas N. Can telemedicine improve CPAP adherence? Thorax. 2010 Dec;65(12):1035-6. doi: 10.1136/thx.2010.140897. Epub 2010 Oct 26. No abstract available.
- Derived from this study: PubMed 31310575Schoch OD, Baty F, Boesch M, Benz G, Niedermann J, Brutsche MH. Telemedicine for Continuous Positive Airway Pressure in Sleep Apnea. A Randomized, Controlled Study. Ann Am Thorac Soc. 2019 Dec;16(12):1550-1557. doi: 10.1513/AnnalsATS.201901-013OC.
- Individual participant dataSharing planned: No
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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.
Martin Brutsche, MD, PhD study director
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine intervention in people with Obstructive Sleep Apnea Syndrome, run by Otto D. Schoch at 1 site in Switzerland.
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 1 inclusion and 7 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 26 Jul 2016. 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 Switzerland. 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?
Proportion of nights with CPAP use (defined as ≥1h of CPAP use per night within the last month including nights of no-use of CPAP) at 6 months (time frame: at 6 months). 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 NCT01715194, which also lists 6 linked publications.
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 26 Jul 2016.