Obstructive Sleep ApneaNCT00131547
Randomized Study of a Simple Weight Loss Program for Obese Patients With Obstructive Sleep Apnea
A study testing Dietary Counseling in people with Obstructive Sleep Apnea, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. 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?
- Dietary Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2004to Aug 2007
- 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
- Patients who have undergone a sleep study at the London Health Sciences Centre or St. Thomas Elgin General Hospital Sleep Laboratory and who are newly diagnosed with obstructive sleep apnea
- Patients with an age over 18 years
- Patients who have an apnea-hypopnea index (AHI) of 5-40 per hour (mild-to-moderate OSA)
- Patients who have an elevated body mass index (BMI) of 28 to 39 kg/m2
- Patients who have an Epworth Sleepiness Scale score ≤11
Who cannot join
- Patients will not be recruited:
- if they are on weight loss medications
- if they have seen a registered dietician in the preceding 6 months for dietary counseling
- if they have attended a weight loss program in the last 6 months
- if they have a history of a car accident related to sleepiness or report sleepiness when driving
- if they work in a safety critical occupation and require treatment for work reasons
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- if they have serious or unstable cardiac co-morbidity
- if they are unable or unwilling to provide informed consent
- if they are pregnant
- if they are unwilling to return for follow-up visits
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Pilot Study of a Simple Weight Loss Program for Obese Patients With Mild to Moderate Obstructive Sleep Apnea
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.
Read the detailed description
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.
Primary Objective
- To determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate OSA when compared to usual care.
- To determine if the amount of weight loss achieved in a 6 month period result in improvements in objective measures of sleep disordered breathing (AHI).
Secondary Objective
- To determine if the weight loss achieved in 6 months result in improvements in OSA symptoms (e.g., snoring, sleepiness) and quality of life.
- To determine if metabolic parameters (e.g., lipids, glucose) improve.
- To determine if there is improvement in sleep structure and oxygenation during sleep.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Dietary Counseling
- Keywords
- Obesity, Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary CounselingBehavioural
Dietary Counseling, use of a food diary and pedometer
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Usual Clinical Care |
| 2 | Experimental | Behavioral (e.g., Counseling) Receives: Behavioral: Dietary Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post treatment weight (kg)
Measured: 6 months
Secondary outcomes (9)
Change in snoring (Visual analogue scale)
Measured: 6 months
Quality of life (FOSQ)
Measured: 6 months
Excessive daytime sleepiness (ESS)
Measured: 6 months
Waist-hip ratio (WHR)
Measured: 6 months
Blood pressure
Measured: 6 months
Lipid and glucose levels
Measured: 6 months
Sleep fragmentation
Measured: 6 months
Oxygen saturation
Measured: 6 months
Post treatment AHI
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2005 (estimated)
- Study startSep 2004
- Primary completionAug 2007
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Lung Association
- Investigators
- Kathleen Ferguson, MD, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00131547
- Sponsor's protocol ID
- R-04-264
- Other IDs
- 10596
- Status last verified
- Oct 2008
- First submitted
- 17 Aug 2005
- Last updated
- 16 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Pilot Study of a Simple Weight Loss Program for Obese Patients With Mild to Moderate Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT00131547
- Acronym / sponsor ID
- R-04-264
- Conditions
- Obstructive Sleep Apnea
- Keywords
- Obesity, Obstructive Sleep Apnea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Ontario Lung Association
- Study start
- Sep 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 18 Aug 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.
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.
Detailed description
The purpose of the study is to determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate obstructive sleep apnea (OSA) when compared to usual patient care. The secondary purpose of the study is to determine if the amount of weight loss achieved in a 6 month period results in improvements in snoring and other symptoms and in the frequency of apnea on overnight monitoring.
Primary Objective
- To determine if weight loss interventions aimed at lifestyle modification (dietary education, food diary pedometer) result in weight loss in patients with mild-moderate OSA when compared to usual care.
- To determine if the amount of weight loss achieved in a 6 month period result in improvements in objective measures of sleep disordered breathing (AHI).
Secondary Objective
- To determine if the weight loss achieved in 6 months result in improvements in OSA symptoms (e.g., snoring, sleepiness) and quality of life.
- To determine if metabolic parameters (e.g., lipids, glucose) improve.
- To determine if there is improvement in sleep structure and oxygenation during sleep.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –Usual Clinical Care |
| 2 | Experimental | Behavioral: Dietary CounselingBehavioral (e.g., Counseling) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who have undergone a sleep study at the London Health Sciences Centre or St. Thomas Elgin General Hospital Sleep Laboratory and who are newly diagnosed with obstructive sleep apnea
- Patients with an age over 18 years
- Patients who have an apnea-hypopnea index (AHI) of 5-40 per hour (mild-to-moderate OSA)
- Patients who have an elevated body mass index (BMI) of 28 to 39 kg/m2
- Patients who have an Epworth Sleepiness Scale score ≤11
Key exclusion criteria (10 listed)
- if they are on weight loss medications
- if they have seen a registered dietician in the preceding 6 months for dietary counseling
- if they have attended a weight loss program in the last 6 months
- if they have a history of a car accident related to sleepiness or report sleepiness when driving
- if they work in a safety critical occupation and require treatment for work reasons
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 |
|---|---|---|
| Dietary CounselingDietary Counseling, use of a food diary and pedometer | Behavioural | 2 |
Primary outcome
Post treatment weight (kg)
Time frame: 6 months
9 secondary outcomes
Change in snoring (Visual analogue scale)
Time frame: 6 months
Quality of life (FOSQ)
Time frame: 6 months
Excessive daytime sleepiness (ESS)
Time frame: 6 months
Waist-hip ratio (WHR)
Time frame: 6 months
Blood pressure
Time frame: 6 months
Lipid and glucose levels
Time frame: 6 months
Sleep fragmentation
Time frame: 6 months
Oxygen saturation
Time frame: 6 months
Post treatment AHI
Time frame: 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 16 Oct 2008.
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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.
Kathleen Ferguson, MD principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Counseling in people with Obstructive Sleep Apnea, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 16 Oct 2008. 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?
Post treatment weight (kg) (time frame: 6 months). 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 16 Oct 2008.