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Effects of surgical and N95 face masks on cardiopulmonary capacity in sleep period

Effects of surgical and N95 face masks on cardiopulmonary capacity in sleep period

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071760
Enrollment
Unknown
Registered
2023-05-24
Start date
2023-05-31
Completion date
Unknown
Last updated
2023-06-12

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

Conditions

healthy volunteer subjects , simple snoring or mild obstructive sleep apnea patients, mild to moderate hypertension or diabetes with good blood pressure/blood glucose control, and no organ damage of heart, brain and kidney.

Interventions

A:no masks, surgical masks, and N95 masks were worn
B:no masks, N95 masks, and surgical masks were worn
C:surgical masks, no masks, and N95 masks were worn
D:surgical masks, N95 masks, and no masks were worn
E:N95 masks, surgical masks, and no masks were worn
F:N95 masks, no masks, and surgical masks were worn

Sponsors

Renmin Hospital of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Healthy volunteer subjects aged 20-65 years, male or female; 2. Simple snoring or mild obstructive sleep apnea aged 20-65 years, male or female; 3. Mild to moderate hypertension or diabetes aged 20-65 years, good blood pressure/blood glucose control, and no organ damage of heart, brain and kidney; 4. The participant himself signs the informed consent form.

Exclusion criteria

Exclusion criteria: 1. SpO2 160/90 mmHg; 8. Patients with serious heart, liver, kidney, and respiratory fuction damage; 9. Lack of the ability to act independently; 10. Severe insomnia and other sleep disorders; 11. Refusing to sign the informed consent form.

Design outcomes

Primary

MeasureTime frame
Sleep monitoring results;lung function before and after bedtime;tidal volume before and after bedtime;blood pressure before and after bedtime; blood rate before and after bedtime; blood oxygen saturation before and after bedtime;

Secondary

MeasureTime frame
Subjective perception of wearing a mask during nighttime sleep;

Countries

China

Contacts

Public ContactHu Ke

Renmin Hospital of Wuhan University

hukejx@163.com+86 189 7103 5988

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026