Suspected Sleep ApneaTelesleepNCT00614952
Cost/Effectiveness Analysis of the Respiratory Poligraphy at Home
A study testing PSG (polysomnography) and PR (respiratory polygraphy) in people with Suspected Sleep Apnea and Daytime Sleepiness, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
Trial summary
The abbreviated diagnostic sleep studies (RP), made at home and transferred telematically to the sleep laboratory, are useful for the diagnosis of sleep apnea and due to a lower cost, it could be an alternative to conventional polysomnography. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Suspected Sleep Apnea, Daytime Sleepiness
- What is being tested?
- PSG (polysomnography) and PR (respiratory polygraphy)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to Jan 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years.
- Without clinical suspicion referred to any other sleep pathology susceptible of presenting daytime sleepiness.
- Living 20 Km or more far from the hospital participating in the study.
Who cannot join
- Psychophysical incapacity to answer questionnaires.
- Patients who do not get pass the proof of placing the PR (see below).
- Patients who present restrictive chronic disease previously diagnosed (neoplasy, any origin chronic pain, renal failure, severe chronic obstructive pulmonary disease and any other limited chronic disease)
- Structural cardiopaty or coronary documented non controlled by means of medical treatment .
- Toxicomanies. Alcoholism (more than 80 gr/day in men and 60 gr/day in women.
- Informed consent not obtained.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital San Pedro de Alcántara. Servicio Extremeño de Salud
Cáceres, Caceres, 10003
About this study
Official title: Diagnostic Validity Study and Cost Analysis of Domiciliary Respiratory
The abbreviated diagnostic sleep studies (RP), made at home and transferred telematically to the sleep laboratory, are useful for the diagnosis of sleep apnea and due to a lower cost, it could be an alternative to conventional polysomnography. Objectives: 1) Usefulness of domiciliary study evaluated by percentage of patients diagnosed of SAHS compared with PSG and agreement in the therapeutic decision. 2) Direct costs of patients included in the study. Design: controlled, randomized, crossed and blind (320 patients) comparing PR made at home with PSG, in patients suspicious of SAHS. The equipment transfer will be made by a transport agency from home to home in order to be universal the access to this diagnostic model. The file transmission with the raw data of the study will be made telematically by GPRS. If the aims of the study reach an end there will be a considerable change in the clinical practice making possible the international acceptation of domiciliary PR as diagnosis of SAHS and adapting the diagnosis of this syndrome to the new technologies of communication. The universalization of domiciliary PR would make possible that the diagnosis of SAHS could be done in any patient and in any country with GPRS technology and a transport agency, that is to say in all developed countries. As sleep apneas affect 5-7 million persons in Spain and there is association between sleep apneas and cardiovascular risk, in the immediate future we must evaluate this disease as we do today with the cholesterol determination. If our results are as predicted, the primary care physician could start and in a lot of cases finish the SAHS diagnostic process. This would simplify remarkably the diagnosis of SAHS and would alleviate a lot the process cost all over the world.
- Conditions
- Suspected Sleep Apnea, Daytime Sleepiness
- Being tested
- PSG (polysomnography), PR (respiratory polygraphy)
- Medical subject headings
- Disorders of Excessive Somnolence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSG (polysomnography)Device
POLYSOMNOGRAPHY
PR (respiratory polygraphy)Other
respiratory polygraphy: level III of AASM
| Study group | Role | What they receive |
|---|---|---|
| PR | Experimental | Not described Receives: Other: PR (respiratory polygraphy) |
| PSG | Active comparator | Not described Receives: Device: PSG (polysomnography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of the two diagnostic models (PR at home and PSG) evaluated by means of percentage of patients who have established the diagnosis of SAHS and agreement in the therapeutic decision.
Measured: at the end of the study
Secondary outcomes (3)
Direct and indirect cost of patients included in the study.
Measured: at the end of the study
Relationship cost/efficacy
Measured: at the end of study
Number of non valid studies in each group
Measured: at the end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suspected Sleep ApneaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad Española de Neumología y Cirugía Torácica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juan F. Masa, Sociedad Española de Neumología y Cirugía Torácica
- Investigators
- Juan F. Masa, MD, Principal investigator, Hospital San Pedro de Alcántara. Cáceres. Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00614952
- Sponsor's protocol ID
- PI 050444
- Acronym
- Telesleep
- Status last verified
- Dec 2012
- First submitted
- 1 Feb 2008
- Last updated
- 20 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Validity Study and Cost Analysis of Domiciliary Respiratory
- ClinicalTrials.gov ID
- NCT00614952
- Acronym / sponsor ID
- Telesleep / PI 050444
- Conditions
- Suspected Sleep Apnea, Daytime Sleepiness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 14 Feb 2008 (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.
The abbreviated diagnostic sleep studies (RP), made at home and transferred telematically to the sleep laboratory, are useful for the diagnosis of sleep apnea and due to a lower cost, it could be an alternative to conventional polysomnography. Objectives: 1) Usefulness of domiciliary study evaluated by percentage of patients diagnosed of SAHS compared with PSG and agreement in the therapeutic decision. 2) Direct costs of patients included in the study. Design: controlled, randomized, crossed and blind (320 patients) comparing PR made at home with PSG, in patients suspicious of SAHS. The equipment transfer will be made by a transport agency from home to home in order to be universal the access to this diagnostic model. The file transmission with the raw data of the study will be made telematically by GPRS. If the aims of the study reach an end there will be a considerable change in the clinical practice making possible the international acceptation of domiciliary PR as diagnosis of SAHS and adapting the diagnosis of this syndrome to the new technologies of communication. The universalization of domiciliary PR would make possible that the diagnosis of SAHS could be done in any patient and in any country with GPRS technology and a transport agency, that is to say in all developed countries. As sleep apneas affect 5-7 million persons in Spain and there is association between sleep apneas and cardiovascular risk, in the immediate future we must evaluate this disease as we do today with the cholesterol determination. If our results are as predicted, the primary care physician could start and in a lot of cases finish the SAHS diagnostic process. This would simplify remarkably the diagnosis of SAHS and would alleviate a lot the process cost all over the world.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PR | Experimental | Other: PR (respiratory polygraphy) |
| PSG | Active comparator | Device: PSG (polysomnography) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 70 years.
- Without clinical suspicion referred to any other sleep pathology susceptible of presenting daytime sleepiness.
- Living 20 Km or more far from the hospital participating in the study.
Key exclusion criteria (6 listed)
- Psychophysical incapacity to answer questionnaires.
- Patients who do not get pass the proof of placing the PR (see below).
- Patients who present restrictive chronic disease previously diagnosed (neoplasy, any origin chronic pain, renal failure, severe chronic obstructive pulmonary disease and any other limited chronic disease)
- Structural cardiopaty or coronary documented non controlled by means of medical treatment .
- Toxicomanies. Alcoholism (more than 80 gr/day in men and 60 gr/day in women.
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 |
|---|---|---|
| PSG (polysomnography)POLYSOMNOGRAPHY | Device | PSG |
| PR (respiratory polygraphy)respiratory polygraphy: level III of AASM | Other | PR |
Primary outcome
Effectiveness of the two diagnostic models (PR at home and PSG) evaluated by means of percentage of patients who have established the diagnosis of SAHS and agreement in the therapeutic decision.
Time frame: at the end of the study
3 secondary outcomes
Direct and indirect cost of patients included in the study.
Time frame: at the end of the study
Relationship cost/efficacy
Time frame: at the end of study
Number of non valid studies in each group
Time frame: at the end of study
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 20 Apr 2016.
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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.
Juan F. Masa, MD principal investigator
Hospital San Pedro de Alcántara. Cáceres. Spain
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSG (polysomnography) and PR (respiratory polygraphy) in people with Suspected Sleep Apnea and Daytime Sleepiness, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.
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 3 inclusion and 6 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 20 Apr 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 Spain. 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?
Effectiveness of the two diagnostic models (PR at home and PSG) evaluated by means of percentage of patients who have established the diagnosis of SAHS and agreement in the therapeutic decision. (time frame: at the end of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Apr 2016.