Autonomic Activity During Nap Under Hypoxia (NAPOXIA)

Charité University Medicine Berlin

Status: Completed

Conditions: Healthy; Hypoxia; Sleep

Treatments: Other: Hypoxia 1; Other: Normoxia; Other: Hypoxia 2

Study type: Interventional

Funder types: Other

Identifiers

NCT04146857

NAPOXIA

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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16 participants in 3 patient groups, including a placebo group

Normoxia

Placebo Comparator group

Description:

20.9% oxygen

Treatment:

Other: Normoxia

Hypoxia 1

Active Comparator group

Description:

15.0% oxygen

Treatment:

Other: Hypoxia 1

Hypoxia 2

Active Comparator group

Description:

12.8% oxygen

Treatment:

Other: Hypoxia 2