NAPOXIA: Autonomic Activity During Nap Under Hypoxia

• Sponsor: Charite University, Berlin, Germany (Other)
• Overall Status: Completed
• CT.gov ID: NCT04146857
• Collaborator: (none)
• Enrollment: 16
• Location: 1
• Arms: 3
• Actual Duration (Months): 14
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypoxia; Sleep; Healthy	Other: Normoxia; Other: Hypoxia 1; Other: Hypoxia 2	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Basic Science
• Official Title: Effects of Normobaric Hypoxia on Autonomic Activity During a Nap in Healthy Adults (NAPOXIA)
• Actual Study Start Date: Oct 30, 2019
• Actual Primary Completion Date: Dec 30, 2020
• Actual Study Completion Date: Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Normoxia 20.9% oxygen	Other: Normoxia; Nap in hypoxia chamber at 20.9% oxygen (36 m asl)
Active Comparator: Hypoxia 1 15.0% oxygen	Other: Hypoxia 1; Nap in hypoxia chamber at 15.0% oxygen (simulates 2660 m asl)
Active Comparator: Hypoxia 2 12.8% oxygen	Other: Hypoxia 2; Nap in hypoxia chamber at 12.8% oxygen (simulates 4000 m asl)

Outcome Measures

Primary Outcome Measures

1. Heart rate variability [During 90 minutes nap under normoxic (20.9%) vs. 12.8% hypoxic condition]

   Mean RR interval measured by polysomnography (ms)

Secondary Outcome Measures

1. Heart rate variability [During 90 minutes nap under normoxic (20.9%) vs. 15.0% hypoxic condition]

   Mean RR interval measured by polysomnography (ms)

2. Sleep Efficiency (SE) [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) [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) [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 45 Years
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Experimental & Clinical Research Center	Berlin		Germany	13125

Sponsors and Collaborators

• Charite University, Berlin, Germany

Investigators

• Principal Investigator: Anja Mähler, PhD, Charite University, Berlin, Germany
• Principal Investigator: Alain Riveros, MD, Charite University, Berlin, Germany

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Results publication

Publications

None provided.

• Responsible Party: Anja Maehler, Principal Investigator, Charite University, Berlin, Germany
• ClinicalTrials.gov Identifier: NCT04146857
• Other Study ID Numbers: NAPOXIA
• First Posted: Oct 31, 2019
• Last Update Posted: Jul 11, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Anja Maehler, Principal Investigator, Charite University, Berlin, Germany: Hypoxia; Sleep; Heart rate variability; Sleep architecture
• Additional relevant MeSH terms: Hypoxia

Study Results

No Results Posted as of Jul 11, 2022