Obstructive Sleep ApneaNCT01001858
Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome
A study testing Diagnosis and monitoring of OSA patients in people with Obstructive Sleep Apnea, run by Hospital Universitario San Juan de Alicante at 1 site in Spain.
Trial summary
The aim of the investigators study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Diagnosis and monitoring of OSA patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2003to Dec 2004
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with high probability of OSA, defined by two or more of :
- daytime sleepiness
- snoring
- recognized apnoeic episodes
- associating obesity and / or hypertension
Who cannot join
- Patients with impaired lung function ( overlap syndrome, obesity-hypoventilation syndrome, restrictive disorders), associated pathology (psychiatric disorder, periodic limb movements, dyssomnias or other parasomnias)
- Patients treated with CPAP
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the investigators study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach.
Read the detailed description
The aim of our study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach.
Detailed Description: We conducted a prospective comparative study. Patients referred for suspected OSAS were evaluated. In the first visit patients completed four questionnaires: Epworth sleepiness scale, Impact Functional Illness Questionnaire (FOSQ), activity questionnaire and symptom questionnaire.
Patients were randomised to three groups:
- Group A (domiciliary group): home based diagnosis by home respiratory polygraphy (RP) and home review conducted by a specialist nurse
- Group B (Hospital group): hospital based diagnosis by polysomnography (PSG) and clinical review conducted by a Pulmonologist
- Group C (mixed group): home based diagnosis by home respiratory polygraphy (RP) and clinical review conducted by a Pulmonologist
Following the diagnostic test (PSG or RP), patients were visited by the Pulmonologist, who identified the need for CPAP treatment.
Patients were evaluated after 1,3 and 6 months of CPAP treatment. In all follow-up visits compliance was evaluated by objective methods and questionnaires described above were filled in.
In domiciliary group, phone calls or hospital appointments were made if low compliance was detected or if some problem with treatment was detected.
Instrumentation.
- Conventional PSG was performed in hospital supervised by a trained nurse. PSG used for the study was Somnostar alfa®. Parameters obtained were: electroencephalogram (C3-A2, C4-A1), electrooculogram electromyogram, electrocardiogram (V2 modified), respiratory effort by thoracic and abdominal resistance bands, air flow with nasal cannula pressure connected to a transducer, oxygen saturation with a pulseoximeter, and snoring with a selective microphone. PSG was manually interpreted in 30 seconds epochs, according to Rechschaffen and Kales criteria.The apnea-hypopnea index (AHI) was defined as the number of apneas-hypopneas divided by the number of hours of sleep. OSA diagnosis was done if AHI was >10 /h.
- Respiratory polygraphy was performed in a non-attended way in patient's home. The nurse who monitorized the patient in the home setting, instructed the patient on the proper use of the RP. A validated respiratory polygraphy system corresponding to ASDA level III (Stardust®) was used. The parameters monitorized were: nasal flow, chest movement, oxyhemoglobin saturation, pulse and body position. The same cardio-respiratory variables that we identified in PSG, were registered. An event rate (number of apneas + number of hypopnea divided by the number of hours recorded)> 15 was considered as a diagnosis. The study were recorded by computer system and manually interpreted by a physician. In case of invalid registration we performed a second PR. If in doubt after the second study a PSG was performed.
Follow-up visits and assessment of compliance:
- Hospital monitoring group: Effective compliance was calculated by mean of the CPAP hour meter, dividing the total number of hours timer by the number of days of use. We discounted 10% of the time, which is the average time of ineffective pressure. Patients were considered adherent if they use CPAP at least 4 hours during 70% of the week
- Follow-up visits by nurses: This group of patients was treated at home through a system of fixed pressure CPAP (REMstar Pro, Respironics ®), with a memory card which can store information about the number of hours of effective pressure. It also allows to know the number of days of CPAP use. In all visits the nurse collect the memory card for later analysis, which was performed by a physician.The nurse responsible for the program evaluated the need of reinforcing in order to get an optimal compliance. If it was considered necessary, the patient was evaluated by the Pulmonologist either by mean of a phone call or of an hospital appointment. All patients in this group were contacted by phone at least once during the first month of CPAP treatment
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Diagnosis and monitoring of OSA patients
- Keywords
- OSA, CPAP compliance, nurse domiciliary led, sleep disease
- 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.
Diagnosis and monitoring of OSA patientsOther
Also called Domiciliary group: group A, Hospital group: group B, Mixed Group: groupC
The difference between the three strategies is given by the method used for OSA diagnosis (domiciliary RP or hospital PSG) and the type of monitoring carried out after initiating CPAP treatment (by physician at hospital or by a trained nurse in patient's home)
| Study group | Role | What they receive |
|---|---|---|
| Domiciliary group | Active comparator | In this group OSA diagnosis was performed at patient's home by mean of non-attended RP. All follow-up visits were conducted by a trained nurse in patient's home. Receives: Other: Diagnosis and monitoring of OSA patients |
| Hospital Group | Active comparator | In this group diagnosis was made by in-hospital PSG. Follow-up was performed at hospital by a specialist Physician Receives: Other: Diagnosis and monitoring of OSA patients |
| Mixed Group | Active comparator | In this group diagnosis was made by home RP, and follow-up at hospital Receives: Other: Diagnosis and monitoring of OSA patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in compliance among the three different strategies, measured by CPAP hours of use
Measured: six months follow-up
Secondary outcomes (1)
costs of the three different strategies, including number of visits and phone calls that were necessary to improve compliance and additional diagnostic tests.
Measured: six months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startJun 2003
- Primary completionDec 2004
- Study completionDec 2004
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 Obstructive 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario San Juan de Alicante
- Sponsor type
- University, hospital or other
- Investigators
- Eusebi Chiner Vives, MD, Study director, Jefe de Sección de Neumología del Hospital San Juan de Alicante. España
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001858
- Sponsor's protocol ID
- 7387
- Status last verified
- Oct 2009
- First submitted
- 7 Oct 2009
- Last updated
- 27 Jul 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Andreu AL, Chiner E, Sancho-Chust JN, Pastor E, Llombart M, Gomez-Merino E, Senent C, Barbe F. Effect of an ambulatory diagnostic and treatment programme in patients with sleep apnoea. Eur Respir J. 2012 Feb;39(2):305-12. doi: 10.1183/09031936.00013311. Epub 2011 Jun 30.
PubMed 21719490
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Domiciliary Diagnosis and Follow up in Obstructive Apnoea Syndrome
- ClinicalTrials.gov ID
- NCT01001858
- Acronym / sponsor ID
- 7387
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, CPAP compliance, nurse domiciliary led, sleep disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hospital Universitario San Juan de AlicanteUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Dec 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 27 Oct 2009 (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 aim of the investigators study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach.
Detailed description
The aim of our study was to evaluate the effectiveness of a home programme (diagnosis and follow-up) in patients with Obstructive Sleep Apnea (OSA) syndrome treated with CPAP and to analyze the cost of this approach.
Detailed Description: We conducted a prospective comparative study. Patients referred for suspected OSAS were evaluated. In the first visit patients completed four questionnaires: Epworth sleepiness scale, Impact Functional Illness Questionnaire (FOSQ), activity questionnaire and symptom questionnaire.
Patients were randomised to three groups:
- Group A (domiciliary group): home based diagnosis by home respiratory polygraphy (RP) and home review conducted by a specialist nurse
- Group B (Hospital group): hospital based diagnosis by polysomnography (PSG) and clinical review conducted by a Pulmonologist
- Group C (mixed group): home based diagnosis by home respiratory polygraphy (RP) and clinical review conducted by a Pulmonologist
Following the diagnostic test (PSG or RP), patients were visited by the Pulmonologist, who identified the need for CPAP treatment.
Patients were evaluated after 1,3 and 6 months of CPAP treatment. In all follow-up visits compliance was evaluated by objective methods and questionnaires described above were filled in.
In domiciliary group, phone calls or hospital appointments were made if low compliance was detected or if some problem with treatment was detected.
Instrumentation.
- Conventional PSG was performed in hospital supervised by a trained nurse. PSG used for the study was Somnostar alfa®. Parameters obtained were: electroencephalogram (C3-A2, C4-A1), electrooculogram electromyogram, electrocardiogram (V2 modified), respiratory effort by thoracic and abdominal resistance bands, air flow with nasal cannula pressure connected to a transducer, oxygen saturation with a pulseoximeter, and snoring with a selective microphone. PSG was manually interpreted in 30 seconds epochs, according to Rechschaffen and Kales criteria.The apnea-hypopnea index (AHI) was defined as the number of apneas-hypopneas divided by the number of hours of sleep. OSA diagnosis was done if AHI was >10 /h.
- Respiratory polygraphy was performed in a non-attended way in patient's home. The nurse who monitorized the patient in the home setting, instructed the patient on the proper use of the RP. A validated respiratory polygraphy system corresponding to ASDA level III (Stardust®) was used. The parameters monitorized were: nasal flow, chest movement, oxyhemoglobin saturation, pulse and body position. The same cardio-respiratory variables that we identified in PSG, were registered. An event rate (number of apneas + number of hypopnea divided by the number of hours recorded)> 15 was considered as a diagnosis. The study were recorded by computer system and manually interpreted by a physician. In case of invalid registration we performed a second PR. If in doubt after the second study a PSG was performed.
Follow-up visits and assessment of compliance:
- Hospital monitoring group: Effective compliance was calculated by mean of the CPAP hour meter, dividing the total number of hours timer by the number of days of use. We discounted 10% of the time, which is the average time of ineffective pressure. Patients were considered adherent if they use CPAP at least 4 hours during 70% of the week
- Follow-up visits by nurses: This group of patients was treated at home through a system of fixed pressure CPAP (REMstar Pro, Respironics ®), with a memory card which can store information about the number of hours of effective pressure. It also allows to know the number of days of CPAP use. In all visits the nurse collect the memory card for later analysis, which was performed by a physician.The nurse responsible for the program evaluated the need of reinforcing in order to get an optimal compliance. If it was considered necessary, the patient was evaluated by the Pulmonologist either by mean of a phone call or of an hospital appointment. All patients in this group were contacted by phone at least once during the first month of CPAP treatment
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Domiciliary group | Active comparator | Other: Diagnosis and monitoring of OSA patientsIn this group OSA diagnosis was performed at patient's home by mean of non-attended RP. All follow-up visits were conducted by a trained nurse in patient's home. |
| Hospital Group | Active comparator | Other: Diagnosis and monitoring of OSA patientsIn this group diagnosis was made by in-hospital PSG. Follow-up was performed at hospital by a specialist Physician |
| Mixed Group | Active comparator | Other: Diagnosis and monitoring of OSA patientsIn this group diagnosis was made by home RP, and follow-up at hospital |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- daytime sleepiness
- snoring
- recognized apnoeic episodes
- associating obesity and / or hypertension
Key exclusion criteria (2 listed)
- Patients with impaired lung function ( overlap syndrome, obesity-hypoventilation syndrome, restrictive disorders), associated pathology (psychiatric disorder, periodic limb movements, dyssomnias or other parasomnias)
- Patients treated with CPAP
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 |
|---|---|---|
| Diagnosis and monitoring of OSA patientsAlso: Domiciliary group: group A, Hospital group: group B, Mixed Group: groupCThe difference between the three strategies is given by the method used for OSA diagnosis (domiciliary RP or hospital PSG) and the type of monitoring carried out after initiating CPAP treatment (by physician at hospital or by a trained nurse in patient's home) | Other | Domiciliary group, Hospital Group, Mixed Group |
Primary outcome
Differences in compliance among the three different strategies, measured by CPAP hours of use
Time frame: six months follow-up
1 secondary outcome
costs of the three different strategies, including number of visits and phone calls that were necessary to improve compliance and additional diagnostic tests.
Time frame: six months follow-up
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 27 Jul 2010.
- Derived from this study: PubMed 21719490Andreu AL, Chiner E, Sancho-Chust JN, Pastor E, Llombart M, Gomez-Merino E, Senent C, Barbe F. Effect of an ambulatory diagnostic and treatment programme in patients with sleep apnoea. Eur Respir J. 2012 Feb;39(2):305-12. doi: 10.1183/09031936.00013311. Epub 2011 Jun 30.
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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.
Eusebi Chiner Vives, MD study director
Jefe de Sección de Neumología del Hospital San Juan de Alicante. España
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnosis and monitoring of OSA patients in people with Obstructive Sleep Apnea, run by Hospital Universitario San Juan de Alicante 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 5 inclusion and 2 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 27 Jul 2010. 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?
Differences in compliance among the three different strategies, measured by CPAP hours of use (time frame: six months follow-up). 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 NCT01001858, 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 27 Jul 2010; AzTrials last refreshed its copy on 7 Nov 2026.