We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 259740 for:    ALL
Previous Study | Return to List | Next Study

Solar Lighting to Reduce Indoor Air Pollution in Rural Uganda

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03351504
First Posted: November 22, 2017
Last Update Posted: November 22, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Mbarara University of Science and Technology
Harvard School of Public Health
Information provided by (Responsible Party):
Peggy S Lai, Massachusetts General Hospital
  Purpose
This study evaluates the impact of a solar lighting system on kerosene lamp use, levels of indoor air pollution, and health in women living in rural Uganda. Half of the participants will receive the lighting systems immediately, while the other half will receive them after an 18 month delay.

Condition Intervention
Pollution; Exposure Hypertension Pollution Related Respiratory Disorder Other: Solar lighting system

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Randomization will be performed using dummy codes to represent intervention and control groups by an independent statistician; blinding of the intervention to the participants and field team is not possible, but data analysis will take place prior to unblinding.
Primary Purpose: Treatment
Official Title: Solar Lighting Intervention Trial to Reduce Indoor Air Pollution and Improve Adult Respiratory Health in Rural Uganda

Resource links provided by NLM:


Further study details as provided by Peggy S Lai, Massachusetts General Hospital:

Primary Outcome Measures:
  • Living room fine particulate matter (PM2.5) [ Time Frame: 48 hour ]
    Area sampling for PM2.5 over 48 hours will be collected


Secondary Outcome Measures:
  • Personal fine particulate matter (PM2.5) [ Time Frame: baseline, 3 months, 6 months, 12 months after the intervention ]
    Personal sampling for PM2.5 over 48 hours will be collected

  • Displacement of original lighting source [ Time Frame: baseline, 3 months, 6 months, 12 months after the intervention ]
    Temperature, lighting, or voltage monitors will be placed on the primary lighting source used by the participants prior to the intervention

  • Blood pressure [ Time Frame: baseline, 3 months, 6 months, 12 months after the intervention ]
    Resting blood pressure

  • Forced Expiratory Volume in one Second (FEV1) [ Time Frame: baseline, 3 months, 6 months, 12 months after the intervention ]
    Pre- and Post- bronchodilator spirometry

  • Heart rate variability [ Time Frame: baseline, 3 months, 6 months, 12 months after the intervention ]
    Resting 10 minute heart rate variability

  • Stool microbiome [ Time Frame: baseline, 3 months, 6 months, 12 months after the intervention ]
    Microbial sequencing of the stool will be performed


Estimated Enrollment: 80
Anticipated Study Start Date: December 1, 2017
Estimated Study Completion Date: October 31, 2020
Estimated Primary Completion Date: October 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control (usual lighting)
Participants will continue to use their usual lighting sources.
Experimental: Intervention (solar lighting)
Participants will receive an indoor solar lighting system
Other: Solar lighting system
consisting of a solar panel, rechargeable lead acid battery, charge controller, wiring and switches to 4 lighting points fitted with LED bulbs. This system will include a two-year service warranty.

Detailed Description:
One fifth of the global population relies on kerosene lamps for lighting, yet few studies have focused on kerosene lighting as a source of indoor air pollution. In our preliminary studies performed in Uganda, we show that homes using solar lighting have much lower levels of indoor air pollution compared to homes using kerosene lighting. The primary goal of this study is to determine the extent to which solar lighting will reduce kerosene use and indoor air pollution in rural Uganda, whether this intervention improves lung health, and to identify the role bacteria in our gut have on determining whether or not people will get sick from indoor air pollution.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women living in Nyakabare Parish, Uganda with no prior history of chronic lung disease

Exclusion Criteria:

  • Current active tuberculosis in any family member
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03351504


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Uganda
Mbarara University of Science and Technology
Mbarara, Uganda
Sponsors and Collaborators
Massachusetts General Hospital
Mbarara University of Science and Technology
Harvard School of Public Health
Investigators
Principal Investigator: Peggy S Lai, MD MPH Massachusetts General Hospital
  More Information

Responsible Party: Peggy S Lai, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03351504     History of Changes
Other Study ID Numbers: 2017P000306/PHS
First Submitted: November 19, 2017
First Posted: November 22, 2017
Last Update Posted: November 22, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Peggy S Lai, Massachusetts General Hospital:
household air pollution
fine particulate matter
kerosene

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract Diseases