Dim Light at Night in Patients With Obstructive Sleep Apnea

NCT01853891 | Withdrawn DMC

• 1 other identifier: 2012H0315
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea (OSA)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

usual condition

NO INTERVENTION

sleep in usual room light condition for 5 nights

dLAN

EXPERIMENTAL

sleep with dim light at night for 5 nights

Other: dim light at night

Interventions

dim light at night OTHER

dLAN

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ulysses Magalang MD: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43221, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Ulysses Magalnag, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 10, 2013
• First Posted: May 15, 2013
• Study Start: February 1, 2013
• Primary Completion: November 1, 2013
• Study Completion: June 1, 2018
• Last Updated: July 30, 2025

Record last verified: 2016-03

Locations

US (1)