NCT01108081

Brief Summary

This project is investigating whether both moderate-intensity physical activity and dietary weight loss will independently reduce sleep apnea symptoms and improve quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2010

Longer than P75 for phase_3

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2010

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2010

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

February 10, 2017

Completed
Last Updated

February 10, 2017

Status Verified

December 1, 2016

Enrollment Period

5.1 years

First QC Date

April 20, 2010

Results QC Date

December 19, 2016

Last Update Submit

December 19, 2016

Conditions

Sleep Apnea

Keywords

Sleep apneaSleep symptomsQuality of Life

Outcome Measures

Primary Outcomes (1)

  • Change Over 6 Months in Epworth Sleepiness Scale Score

    Epworth Sleepiness Scale score, change in score from baseline to 6 months. Total scores range from 0-24, where higher scores indicate more sleepiness.

    baseline and 6 months

Secondary Outcomes (1)

  • Change Over 6 Months in Quality of Life

    baseline and 6 months

Study Arms (4)

Arm 1

EXPERIMENTAL

Physical activity

Behavioral: Physical activity

Arm 2

EXPERIMENTAL

Diet

Behavioral: Diet

Arm 3

ACTIVE COMPARATOR

Health education

Behavioral: Health education

Arm 4

EXPERIMENTAL

Combined physical activity and diet

Behavioral: Physical activityBehavioral: Diet

Interventions

Physical activityBEHAVIORAL

Moderate-intensity physical activity

Arm 1Arm 4
DietBEHAVIORAL

Dietary weight loss

Arm 2Arm 4
Health educationBEHAVIORAL

Attention control intervention

Arm 3

Eligibility Criteria

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

You may qualify if:

  • Physician diagnosis of sleep apnea
  • Apnea-hypopnea index \>10/hr
  • BMI over 24 kg/m2

You may not qualify if:

  • Angina pectoris
  • History of myocardial infarction within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Sleep Apnea Syndromes

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

ApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Results Point of Contact

Title
Dr. David Sparrow
Organization
VA Boston Healthcare System
david.sparrow@va.gov
857-364-6400

Study Officials

  • David W Sparrow, DSc

    VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
FACTORIAL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2010

First Posted

April 21, 2010

Study Start

October 1, 2010

Primary Completion

November 1, 2015

Study Completion

January 1, 2016

Last Updated

February 10, 2017

Results First Posted

February 10, 2017

Record last verified: 2016-12

Locations

US(1)