Dim Light at Night in Patients With Obstructive Sleep Apnea

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01853891
• Other study ID #: 2012H0315
• Status: Withdrawn
• Phase: N/A
• First received: May 10, 2013
• Last updated: March 28, 2016
• Start date: February 2013

Study information

• Verified date: March 2016
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea (OSA)
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• dim light at night

Locations

Country	Name	City	State
United States	The Ohio State University	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ulysses Magalang MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposure to Dim Light at Night	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).	5 consecutive nights	No