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OpenTrials
Completed

NCT Number: NCT04146857

Autonomic Activity During Nap Under Hypoxia

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.

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Key information

Conditions

Hypoxia Healthy Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Sleep

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Experimental & Clinical Research Center

Berlin, 13125, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Normoxia

Other

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

Hypoxia 1

Other

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

Hypoxia 2

Other

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

Primary outcomes

  1. 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

  1. Heart rate variability

    Time frame: During 90 minutes nap under normoxic (20.9%) vs. 15.0% hypoxic condition

    Mean RR interval measured by polysomnography (ms)

  2. Sleep Efficiency (SE)

    Time frame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

    Measured by continuous polysomnography (min)

  3. Wake After Sleep Onset (WASO)

    Time frame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

    Measured by continuous polysomnography (min)

  4. Sleep Onset Latency (SOL)

    Time frame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

    Measured by continuous polysomnography (min)

  5. Low Frequency / High Frequency Band

    Time frame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

    Mean LF/HF ratio measured by continuous ECG

  6. Standard Deviation 1 / Standard Deviation 2

    Time frame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

    Mean SD1/SD2 ratio measured by continuous ECG

  7. RR intervals longer than 50 ms

    Time frame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

    Percentage pNN50 measured by continuous ECG (%)

  8. Core Body Temperature

    Time frame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

    Mean temperature measured by continuous double sensor monitoring (°C)

  9. Skin Temperature

    Time frame: During 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

    Mean temperature measured by continuous double sensor monitoring (°C)

  10. Digit Span Task

    Time frame: After 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)

  11. Psychomotor Vigilance Task Subscale 1

    Time frame: After 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)

  12. Psychomotor Vigilance Task Subscale 2

    Time frame: After 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)

  13. Color Stroope Task Subscale 1

    Time frame: After 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)

  14. Color Stroope Task Subscale 2

    Time frame: After 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)

  15. Color Stroope Task Subscale 3

    Time frame: After 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)

  16. Color Stroope Task Subscale 4

    Time frame: After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

    Congruent accuracy (above 95% is normal, higher is better)

  17. Color Stroope Task Subscale 5

    Time frame: After 90 minutes nap under normoxic (20.9%) vs. two hypoxic conditions (12.8 and 15%)

    Incongruent accuracy (above 85% is normal, higher is better)

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

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

Acronym: NAPOXIA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 31, 2019
Registry last updated
Jul 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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