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Autonomic Activity During Nap Under Hypoxia (NAPOXIA)

Primary Purpose

Hypoxia, Sleep, Healthy

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

Normoxia

Hypoxia 1

Hypoxia 2

About this trial

This is an interventional basic science trial for Hypoxia focused on measuring Hypoxia, Sleep, Heart rate variability, Sleep architecture

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Experimental & Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Normoxia

Hypoxia 1

Hypoxia 2

Arm Description

20.9% oxygen

15.0% oxygen

12.8% oxygen

Outcomes

Primary Outcome Measures

Heart rate variability

Mean RR interval measured by polysomnography (ms)

Secondary Outcome Measures

Heart rate variability

Mean RR interval measured by polysomnography (ms)

Sleep Efficiency (SE)

Measured by continuous polysomnography (min)

Wake After Sleep Onset (WASO)

Measured by continuous polysomnography (min)

Sleep Onset Latency (SOL)

Measured by continuous polysomnography (min)

Low Frequency / High Frequency Band

Mean LF/HF ratio measured by continuous ECG

Standard Deviation 1 / Standard Deviation 2

Mean SD1/SD2 ratio measured by continuous ECG

RR intervals longer than 50 ms

Percentage pNN50 measured by continuous ECG (%)

Core Body Temperature

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

Skin Temperature

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

Digit Span Task

Longest memorized digit series (n, normal range 5-9, higher is better)

Psychomotor Vigilance Task Subscale 1

Number of lapses (normal range 0-6, higher is worse)

Psychomotor Vigilance Task Subscale 2

Mean reaction time (normal range 100-500 ms, higher is worse)

Color Stroope Task Subscale 1

Number of incongruency errors (normal range 0-5, higher is worse)

Color Stroope Task Subscale 2

Congruent response time (normal range 400-500 ms, higher is worse)

Color Stroope Task Subscale 3

Incongruent response time (normal range 600-800 ms, higher is worse)

Color Stroope Task Subscale 4

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

Color Stroope Task Subscale 5

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

Full Information

NCT ID

NCT04146857

First Posted

October 25, 2019

Last Updated

July 7, 2022

Sponsor

Charite University, Berlin, Germany

1. Study Identification

Unique Protocol Identification Number

NCT04146857

Brief Title

Autonomic Activity During Nap Under Hypoxia

Acronym

NAPOXIA

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Completed

Study Start Date

October 30, 2019 (Actual)

Primary Completion Date

December 30, 2020 (Actual)

Study Completion Date

December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Charite University, Berlin, Germany

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxia, Sleep, Healthy

Keywords

Hypoxia, Sleep, Heart rate variability, Sleep architecture

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Randomized

Enrollment

16 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Normoxia

Arm Type

Placebo Comparator

Arm Description

20.9% oxygen

Arm Title

Hypoxia 1

Arm Type

Active Comparator

Arm Description

15.0% oxygen

Arm Title

Hypoxia 2

Arm Type

Active Comparator

Arm Description

12.8% oxygen

Intervention Type

Other

Intervention Name(s)

Normoxia

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Hypoxia 1

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Hypoxia 2

Intervention Description

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

Primary Outcome Measure Information:

Title

Heart rate variability

Description

Mean RR interval measured by polysomnography (ms)

Time Frame

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

Secondary Outcome Measure Information:

Title

Heart rate variability

Description

Mean RR interval measured by polysomnography (ms)

Time Frame

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

Title

Sleep Efficiency (SE)

Description

Measured by continuous polysomnography (min)

Time Frame