Dim Light at Night in Patients With Obstructive Sleep Apnea

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea (OSA)
• Interventions: Other: dim light at night

• Registration Number: NCT01853891
• Lead Sponsor: Ulysses Magalang MD

Brief Summary

With the advent of electricity, light at night has become a ubiquitous part of our society.

The main purpose of this study is to determine whether sleeping with dim light (40 lux), the brightness of a night light) in your bedroom for 5 consecutive nights will result in increased markers of inflammation in the blood compared to sleeping in darkness during the night in patients with obstructive sleep apnea (OSA).

A secondary aim is to examine the effects on insulin sensitivity, other blood proteins, and RNA molecules as a result of sleeping with dim light. RNA molecules are substances in blood that dictate what type of proteins the body should make.

Detailed Description

The primary objective of this study is to determine whether sleeping with dLAN (40 lux) for 5 consecutive nights will result in increased markers of inflammation compared to sleeping in darkness (\< 1 lux) during the night in patients with OSA. A secondary aim is to examine the effects on insulin sensitivity, adipokines, and RNA molecules.

The risks associated with this study are minimal compared to the potential benefits. Knowledge about the effects of sleeping with dim light on inflammation in patients with OSA is important and would guide future recommendations about proper sleep hygiene. This research may also guide future recommendations about light conditions in other environments such as hospital bedrooms.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-05-10
• Study First Submitted QC: 2013-05-10
• Study First Posted: 2013-05-15
• Primary Completion: 2013-11
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-28
• Last Update Posted: 2016-03-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• • 18 -60 years of age.

  • Willing and able to give informed consent
  • AHI >10 episodes per hour based on a prior PSG.
  • Patients who have been started on treatment for OSA with either Continuous Positive Airway Pressure (CPAP) or dental device will be eligible for the study as long as they have been compliant with treatment for at least 30 days.

Exclusion Criteria

• • Incapable of giving informed consent

  • Under the age of 18

  • Currently sleeping with lights on in the bedroom

  • Excessive alcohol consumption

    • Excessive alcohol use is defined as:
    • More than 3 glasses of wine a day
    • More than 3 beers a day
    • More than 60 mL of hard liquor a day

  • Room air oxyhemoglobin saturation < 88%

  • Use of home oxygen

  • Use of corticosteroids and other immunosuppressive medications.

  • Diagnosis of: HIV, Connective Tissue Disease (Lupus, Rheumatoid arthritis), Inflammatory Bowel Disease.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
dLAN	dim light at night	sleep with dim light at night for 5 nights

Primary Outcome Measures

Name	Time	Method
Exposure to Dim Light at Night	5 consecutive nights	The main purpose of this study is to determine whether sleeping with dim light (40 lux), the brightness of a night light) in your bedroom for 5 consecutive nights will result in increased markers of inflammation in the blood compared to sleeping in darkness during the night in patients with obstructive sleep apnea (OSA).

Trial Locations

Locations (1)

The Ohio State University; 🇺🇸 Columbus, Ohio, United States