Obstructive Sleep ApneaNCT00254059
A Randomized Study to Compare Polysomnography With Overnight Home Oximetry and Auto - CPAP for Sleep Apnea
A study testing Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnography in people with Obstructive Sleep Apnea, run by University of British Columbia at 1 site in Canada.
Trial summary
This study will look at an alternative new pathway for diagnosis and treatment based on simple procedures in the patient's own home compared with the current conventional laboratory based pathway. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnography
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Start not givento 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Residence in the Lower Mainland
- History and physical examination findings compatible with OSAHS
- Normal spirometry. (This is necessary to avoid decreased specificity of overnight oximetry attributable to underlying lung disease)
- Epworth Sleepiness Scale > 10
Who cannot join
- Age < 18 years
- Pregnancy
- Other known disorders that cause daytime sleepiness
- Requiring sedative/hypnotic medications
- Psychiatric disorder
- Life threatening co-morbidity e.g. chronic lung disease, coronary artery disease - unstable angina, recent myocardial infarction, heart failure, seizure disorder, and previous motor vehicle accident attributed to hypersomnolence
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- Language barrier
- Inability to give informed consent
- Contraindication to nasal CPAP therapy
- Previous treatment of OSAHS with nasal CPAP, oral appliance therapy or corrective upper airway surgery.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Vancouver Coastal Health Research Institute, Respiratory Division
Vancouver, British Columbia
About this study
Official title: A Randomized Study to Compare Polysomnography With Overnight Home Oximetry and Auto - CPAP for Diagnosis and Nasal CPAP Titration in Patients With a High Probability of Obstructive Sleep Apnea.
This study will look at an alternative new pathway for diagnosis and treatment based on simple procedures in the patient's own home compared with the current conventional laboratory based pathway. The purpose is to determine whether all patients with OSA require the more elaborate laboratory procedures, or whether a subgroup can be managed more simply.
Read the detailed description
The research question we are exploring is whether the conventional approach is better in terms of successful treatment, compliance with treatment, and quality of life. There will be 2 arms to the study. Subject will be randomly assigned to either one of the following two treatment options: 1) the conventional investigation and nasal CPAP treatment pathway comprising 2 overnight sleep studies, one for diagnosis and one for determining the required level of nasal CPAP treatment 2) experimental pathway that uses a simplified home study (overnight oximetry), together with a machine that automatically adjusts the nasal CPAP pressure to the required amount, and a careful follow-up during the first 2 weeks of treatment.
Procedures: The study protocol will require the subject to complete the following procedures which are part of routine clinical practice: History and Physical Examination by a physician, Home Oximetry (This simple test involves wearing an oxygen probe gently wrapped around subject's finger during a night's sleep to continuously measure the amount of oxygen in blood and detect obstructions of subject's breathing. The probe is easily applied by the subject and requires no supervision), Spirometry (simple non-invasive breathing test), Standardized Sleepiness Questionnaires, Orientation and Education regarding nasal CPAP therapy, and compliance monitoring, Overnight polysomnography (This is the procedure that requires subject to spend a night in the sleep laboratory with a variety of painless and non-invasive monitoring devices attached to the body. The purpose is to obtain detailed information about subject's sleep quality, breathing, heart function, and body movements during sleep. Subject will be continuously monitored by a trained technologist during this procedure.). The following procedures are not routine and subject may be required to complete some or all of them depending on which pathway assigned to. Follow-up visits to the Clinic on Days 7 and 14 of nasal CPAP treatment for adjustments of nasal CPAP pressure as required (this could also be done at home), Repeat Home Oximetry as required, Quality of Life Questionnaire.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnography
- Keywords
- OSAHS, OSA, CPAP, polysomnography, overnight oximetry, Obstructive sleep apnea, apnea hypopnea index, AHI, Obstructive Sleep Apnea Hypopnea Syndrome
- Medical subject headings
- Sleep Apnea, Obstructive, Microcephaly, Primary Autosomal Recessive, 6
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnographyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome measurement will be apnea-hypopnea index (AHI) during a full night polysomnogram performed on the effective nasal CPAP pressure after 3 months of nasal CPAP therapy.
Secondary outcomes (4)
1. The study will also compare CPAP pressure between the two groups after 3 months of therapy.
2. This study will compare Epworth Sleepiness Score, arousal index and sleep efficiency index between the two groups after 3 months of therapy.
3. This study will compare Sleep Apnea Quality of Life Index between the two groups after 3 months of therapy.
4. It will compare the change in Sleep Apnea Quality of Life Index from baseline to follow-up between the two groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- 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.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Investigators
- Frank Ryan, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00254059
- Sponsor's protocol ID
- C03-0079
- Status last verified
- Nov 2005
- First submitted
- 10 Nov 2005
- Last updated
- 15 Nov 2005
- Results posted
- No
Publications
Mulgrew AT, Fox N, Ayas NT, Ryan CF. Diagnosis and initial management of obstructive sleep apnea without polysomnography: a randomized validation study. Ann Intern Med. 2007 Feb 6;146(3):157-66. doi: 10.7326/0003-4819-146-3-200702060-00004.
PubMed 17283346
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Compare Polysomnography With Overnight Home Oximetry and Auto - CPAP for Diagnosis and Nasal CPAP Titration in Patients With a High Probability of Obstructive Sleep Apnea.
- ClinicalTrials.gov ID
- NCT00254059
- Acronym / sponsor ID
- C03-0079
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSAHS, OSA, CPAP, polysomnography, overnight oximetry, Obstructive sleep apnea, apnea hypopnea index, AHI, Obstructive Sleep Apnea Hypopnea Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study completion
- Dec 2004
- First posted
- 15 Nov 2005 (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.
This study will look at an alternative new pathway for diagnosis and treatment based on simple procedures in the patient's own home compared with the current conventional laboratory based pathway. The purpose is to determine whether all patients with OSA require the more elaborate laboratory procedures, or whether a subgroup can be managed more simply.
Detailed description
The research question we are exploring is whether the conventional approach is better in terms of successful treatment, compliance with treatment, and quality of life. There will be 2 arms to the study. Subject will be randomly assigned to either one of the following two treatment options: 1) the conventional investigation and nasal CPAP treatment pathway comprising 2 overnight sleep studies, one for diagnosis and one for determining the required level of nasal CPAP treatment 2) experimental pathway that uses a simplified home study (overnight oximetry), together with a machine that automatically adjusts the nasal CPAP pressure to the required amount, and a careful follow-up during the first 2 weeks of treatment.
Procedures: The study protocol will require the subject to complete the following procedures which are part of routine clinical practice: History and Physical Examination by a physician, Home Oximetry (This simple test involves wearing an oxygen probe gently wrapped around subject's finger during a night's sleep to continuously measure the amount of oxygen in blood and detect obstructions of subject's breathing. The probe is easily applied by the subject and requires no supervision), Spirometry (simple non-invasive breathing test), Standardized Sleepiness Questionnaires, Orientation and Education regarding nasal CPAP therapy, and compliance monitoring, Overnight polysomnography (This is the procedure that requires subject to spend a night in the sleep laboratory with a variety of painless and non-invasive monitoring devices attached to the body. The purpose is to obtain detailed information about subject's sleep quality, breathing, heart function, and body movements during sleep. Subject will be continuously monitored by a trained technologist during this procedure.). The following procedures are not routine and subject may be required to complete some or all of them depending on which pathway assigned to. Follow-up visits to the Clinic on Days 7 and 14 of nasal CPAP treatment for adjustments of nasal CPAP pressure as required (this could also be done at home), Repeat Home Oximetry as required, Quality of Life Questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age > 18 years
- Residence in the Lower Mainland
- History and physical examination findings compatible with OSAHS
- Normal spirometry. (This is necessary to avoid decreased specificity of overnight oximetry attributable to underlying lung disease)
- Epworth Sleepiness Scale > 10
Key exclusion criteria (10 listed)
- Age < 18 years
- Pregnancy
- Other known disorders that cause daytime sleepiness
- Requiring sedative/hypnotic medications
- Psychiatric disorder
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 |
|---|---|---|
| Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnography | Procedure or surgery | – |
Primary outcome
The primary outcome measurement will be apnea-hypopnea index (AHI) during a full night polysomnogram performed on the effective nasal CPAP pressure after 3 months of nasal CPAP therapy.
4 secondary outcomes
1. The study will also compare CPAP pressure between the two groups after 3 months of therapy.
2. This study will compare Epworth Sleepiness Score, arousal index and sleep efficiency index between the two groups after 3 months of therapy.
3. This study will compare Sleep Apnea Quality of Life Index between the two groups after 3 months of therapy.
4. It will compare the change in Sleep Apnea Quality of Life Index from baseline to follow-up between the two groups.
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 15 Nov 2005.
- Derived from this study: PubMed 17283346Mulgrew AT, Fox N, Ayas NT, Ryan CF. Diagnosis and initial management of obstructive sleep apnea without polysomnography: a randomized validation study. Ann Intern Med. 2007 Feb 6;146(3):157-66. doi: 10.7326/0003-4819-146-3-200702060-00004.
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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.
Frank Ryan, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambulatory diagnosis and titration with nasal CPAP using over night oxymetry and auto CPAP and vs conventional diagnosis and titration using polysomnography in people with Obstructive Sleep Apnea, run by University of British Columbia at 1 site in Canada.
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 10 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 15 Nov 2005. 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 Canada. 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?
The primary outcome measurement will be apnea-hypopnea index (AHI) during a full night polysomnogram performed on the effective nasal CPAP pressure after 3 months of nasal CPAP therapy.. 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 NCT00254059, 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 15 Nov 2005.