Skip to content

Autonomic Activity During Nap Under Hypoxia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04146857
Acronym
NAPOXIA
Enrollment
16
Registered
2019-10-31
Start date
2019-10-30
Completion date
2020-12-30
Last updated
2022-07-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypoxia, Sleep, Healthy

Keywords

Hypoxia, Sleep, Heart rate variability, Sleep architecture

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.

Interventions

Nap in hypoxia chamber at 20.9% oxygen (36 m asl)

OTHERHypoxia 1

Nap in hypoxia chamber at 15.0% oxygen (simulates 2660 m asl)

OTHERHypoxia 2

Nap in hypoxia chamber at 12.8% oxygen (simulates 4000 m asl)

Sponsors

Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
25 Years to 45 Years
Healthy volunteers
Yes

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 * Smoking * Athletes * Significant weight change within 1 month before enrollment * Inability to understand significance and scope of the study * Drug or alcohol abuse

Design outcomes

Primary

MeasureTime frameDescription
Heart rate variabilityDuring 90 minutes nap under normoxic (20.9%) vs. 12.8% hypoxic conditionMean RR interval measured by polysomnography (ms)

Secondary

MeasureTime frameDescription
Sleep Efficiency (SE)During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Measured by continuous polysomnography (min)
Wake After Sleep Onset (WASO)During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Measured by continuous polysomnography (min)
Sleep Onset Latency (SOL)During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Measured by continuous polysomnography (min)
Low Frequency / High Frequency BandDuring 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Mean LF/HF ratio measured by continuous ECG
Standard Deviation 1 / Standard Deviation 2During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Mean SD1/SD2 ratio measured by continuous ECG
RR intervals longer than 50 msDuring 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Percentage pNN50 measured by continuous ECG (%)
Core Body TemperatureDuring 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Mean temperature measured by continuous double sensor monitoring (°C)
Skin TemperatureDuring 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Mean temperature measured by continuous double sensor monitoring (°C)
Heart rate variabilityDuring 90 minutes nap under normoxic (20.9%) vs. 15.0% hypoxic conditionMean RR interval measured by polysomnography (ms)
Psychomotor Vigilance Task Subscale 1After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Number of lapses (normal range 0-6, higher is worse)
Psychomotor Vigilance Task Subscale 2After 90 min nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Mean reaction time (normal range 100-500 ms, higher is worse)
Color Stroope Task Subscale 1After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Number of incongruency errors (normal range 0-5, higher is worse)
Color Stroope Task Subscale 2After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Congruent response time (normal range 400-500 ms, higher is worse)
Color Stroope Task Subscale 3After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Incongruent response time (normal range 600-800 ms, higher is worse)
Color Stroope Task Subscale 4After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Congruent accuracy (above 95% is normal, higher is better)
Color Stroope Task Subscale 5After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Incongruent accuracy (above 85% is normal, higher is better)
Digit Span TaskAfter 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)Longest memorized digit series (n, normal range 5-9, higher is better)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026