NCT00131547

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

October 16, 2008

Status Verified

October 1, 2008

Enrollment Period

2.9 years

First QC Date

August 17, 2005

Last Update Submit

October 15, 2008

Conditions

Obstructive Sleep Apnea

Keywords

ObesityObstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

  • Post treatment weight (kg)

    6 months

Secondary Outcomes (9)

  • Change in snoring (Visual analogue scale)

    6 months

  • Quality of life (FOSQ)

    6 months

  • Excessive daytime sleepiness (ESS)

    6 months

  • Waist-hip ratio (WHR)

    6 months

  • Blood pressure

    6 months

  • +4 more secondary outcomes

Study Arms (2)

1

NO INTERVENTION

Usual Clinical Care

2

EXPERIMENTAL

Behavioral (e.g., Counseling)

Behavioral: Dietary Counseling

Interventions

Dietary CounselingBEHAVIORAL

Dietary Counseling, use of a food diary and pedometer

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 4G5, Canada

Location

MeSH Terms

Conditions

Sleep Apnea, ObstructiveObesity

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Kathleen Ferguson, MD

    Western University, Canada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 17, 2005

First Posted

August 18, 2005

Study Start

September 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

October 16, 2008

Record last verified: 2008-10

Locations

CA(1)