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Clinical Trials/NCT01853891
NCT01853891WithdrawnNot Applicable

Effects of Sleeping With Dim Light at Night in Patients With Obstructive Sleep Apnea

Ulysses Magalang MD1 site in 1 countryStarted: February 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Withdrawn
Sponsor
Locations
1
Primary Endpoint
Exposure to Dim Light at Night

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Other
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

usual condition

No Intervention

sleep in usual room light condition for 5 nights

dLAN

Experimental

sleep with dim light at night for 5 nights

Intervention: dim light at night (Other)

Outcomes

Primary Outcomes

Exposure to Dim Light at Night

Time Frame: 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).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Ulysses Magalang MD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ulysses Magalang MD

Professor

Ohio State University

Study Sites (1)

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