Effects of Normobaric Hypoxia on Autonomic Activity During a Nap in Healthy Adults (NAPOXIA)

Charite University, Berlin, Germany1 site in 1 country16 target enrollmentOctober 30, 2019

ConditionsHypoxia Sleep Healthy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Hypoxia
Sponsor: Charite University, Berlin, Germany
Enrollment: 16
Locations: 1
Primary Endpoint: Heart rate variability
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Sleeping under hypoxic conditions can impair cognition and autonomic nervous activity. A short daytime nap can modify these changes. Here we propose a randomized, cross-over study to evaluate the heart rate variability during a 90 min nap in a normobaric hypoxic chamber. In addition, we will investigate sleep architecture, vigilance, attention and memory.

Registry

clinicaltrials.gov

Start Date

October 30, 2019

End Date

December 30, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Charite University, Berlin, Germany

Responsible Party

Principal Investigator

Anja Maehler

Principal Investigator

Charite University, Berlin, Germany

Eligibility Criteria

Inclusion Criteria

•Men and women
•Age 25-45 years
•BMI 20 - 28 kg/m\^2

Exclusion Criteria

•Severe, manifest illnesses in need of treatment
•Postoperative phases
•Acute and chronic infections
•Sleep disorders such as sleep apnea, insomnia or somnolence
•Altitude exposure (\> 2500 m asl) within 6 months before enrollment
•Regular migraines
•Significant weight change within 1 month before enrollment
•Inability to understand significance and scope of the study
•Drug or alcohol abuse

Outcomes

Primary Outcomes

Heart rate variability

Time Frame: During 90 minutes nap under normoxic (20.9%) vs. 12.8% hypoxic condition

Mean RR interval measured by polysomnography (ms)

Secondary Outcomes

Wake After Sleep Onset (WASO)(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Digit Span Task(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Low Frequency / High Frequency Band(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
RR intervals longer than 50 ms(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Psychomotor Vigilance Task Subscale 2(After 90 min nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Color Stroope Task Subscale 4(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Sleep Onset Latency (SOL)(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Heart rate variability(During 90 minutes nap under normoxic (20.9%) vs. 15.0% hypoxic condition)
Sleep Efficiency (SE)(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Standard Deviation 1 / Standard Deviation 2(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Skin Temperature(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Color Stroope Task Subscale 1(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Core Body Temperature(During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Psychomotor Vigilance Task Subscale 1(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Color Stroope Task Subscale 2(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Color Stroope Task Subscale 3(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))
Color Stroope Task Subscale 5(After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%))