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Design Beyond Comfort: A Pilot Study on the Critical Role of Ambient Temperature on Sleep Quality and Duration of Occupants in Built environment

Protocol summary

Study aim
The main objective of this study is to compare thermal comfort during sleep across Tehran climate with similar international studies, and to analyze the influence of individuals’ bioclimatic background on their thermal perception and physiological responses during sleep.
Design
A controlled clinical trial (21 degrees), with crossover groups at 18 and 24 degrees, non-blinded, randomized, on 6 participants. The Excel "rand" function was used to randomize the order of participants in the clinical trial.
Settings and conduct
Occupational Sleep Disorder Lab, Baharloo Hospital Procedure: Adjust room temperature; subject enters, changes into test attire, attaches PSG device, sets up temperature and humidity loggers, completes questionnaires on thermal comfort and sensation, measures physiological and environmental factors during sleep, and fills out 5-point Likert scale questionnaires on sleep quality and comfort after waking.
Participants/Inclusion and exclusion criteria
- No addiction to alcohol, psychoactive substances, or cigarettes - No diseases or sleep disorders with a PSQI index equal or below 5 scores - Having a healthy body mass index - Male -age between 20 and 25 years
Intervention groups
This study examines the impact of dry air temperature in three intervals (18°C-21°C - 24°C) and operative temperature on sleep quality and duration in three different nights.
Main outcome variables
Total Sleep Time; Slow-Wave Sleep Duration; Sleep Efficiency; Stage durations: N1, N2, N3, REM; Number of Awakenings; Subjective Sleep Quality; Mean skin Temperature; Subjective Thermal Comfort

General information

Reason for update
Acronym
EBS
IRCT registration information
IRCT registration number: IRCT20250330065178N1
Registration date: 2025-04-17, 1404/01/28
Registration timing: registered_while_recruiting

Last update: 2025-04-17, 1404/01/28
Update count: 0
Registration date
2025-04-17, 1404/01/28
Registrant information
Name
Hasti Beykpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3434 9684
Email address
hasti.beyk@edu.ikiu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-03-30, 1404/01/10
Expected recruitment end date
2025-05-05, 1404/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design Beyond Comfort: A Pilot Study on the Critical Role of Ambient Temperature on Sleep Quality and Duration of Occupants in Built environment
Public title
An Environment for a Better Sleep
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
No addiction to drugs or cigarette or alcoholic drinks No Chronic diseases No Sleep disorders with PSQI equal or under 5 scores Healthy BMI Age range of 20 to 25 years, with a maximum standard deviation of 1.5 years
Exclusion criteria:
over or under weight addiction to drugs or cigarette or alcoholic drinks Having chronic diseases like high blood pressure Having Sleep disorders or PSQI higher than 5 scores Age outside the age range examined in the study
Age
From 20 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 6
More than 1 sample in each individual
Number of samples in each individual: 3
Each person sleeps under 3 different temperatures for three nights.
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee in Biomedical Research, School of Medicine, Tehran University of Medical Sciences
Street address
Ethics Committee of Biological Research, Room 604, 6th Floor, Central Building of Tehran University of Medical Sciences, Qods Street, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2025-03-04, 1403/12/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1403.673

Health conditions studied

1

Description of health condition studied
Investigation of Sleep Quality Under Different Temperature Conditions
ICD-10 code
G47.9
ICD-10 code description
Sleep disorder, unspecified

Primary outcomes

1

Description
Sleep Efficiency
Timepoint
Physiological parameter measurements are taken at intervals of 10 to 30 seconds.
Method of measurement
The device and method for measuring the outcome variable is polysomnography.

2

Description
Total sleep time
Timepoint
Physiological parameter measurements are taken at intervals of 10 to 30 seconds.
Method of measurement
The device and method for measuring the outcome variable is polysomnography.

3

Description
Slow-wave sleep duration
Timepoint
Physiological parameter measurements are taken at intervals of 10 to 30 seconds.
Method of measurement
The device and method for measuring the outcome variable is polysomnography.

4

Description
Stage durations: N1, N2, N3, REM
Timepoint
Physiological parameter measurements are taken at intervals of 10 to 30 seconds.
Method of measurement
The device and method for measuring the outcome variable is polysomnography.

5

Description
Number of Awakenings
Timepoint
Physiological parameter measurements are taken at intervals of 10 to 30 seconds.
Method of measurement
The device and method for measuring the outcome variable is polysomnography.

6

Description
Subjective Sleep quality
Timepoint
The morning after waking from every test.
Method of measurement
5-Point Likert Scale Questionnaire

7

Description
Mean Skin Temperature
Timepoint
Physiological parameter measurements are taken at intervals of 10 to 30 seconds.
Method of measurement
Using a medical temperature probe

8

Description
Thermal comfort Vote
Timepoint
Before and after each night's test.
Method of measurement
5-Point Likert Scale Questionnaire

9

Description
Thermal Sensation Vote
Timepoint
Before and after each night's test.
Method of measurement
7-Point Likert Scale Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention Group 1: Participants will sleep in a temperature-controlled room at 18 degrees Celsius, with regulated humidity, darkness, sound, light, and standardized bedding. Their physiological data will be recorded using polysomnography (EEG, EMG, and EOG). Each individual's experiment will last one full night at this temperature.
Category
Lifestyle

2

Description
Intervention Group 2: The conditions are the same as in Intervention Group 1, with the difference that the room temperature in this group is set to a constant 24 degrees Celsius. Other conditions (environment, clothing, equipment, data recording) are identical.
Category
Lifestyle

3

Description
Control Group: The conditions are similar to the two intervention groups, but the room temperature in this group is set to a constant 21 degrees Celsius, which is considered the general thermal equilibrium temperature.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Sleep Disorders Research Center of Baharloo Hospital
Full name of responsible person
Dr. Khosrow Sadegh Neit
Street address
Occupational Sleep Disorder Research Center, Ground Floor, Building No. 2, Baharloo Hospital, Behboudi Square, Rah Ahan Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1339973111
Phone
+98 21 5546 0184
Fax
Email
osrc@tums.ac.ir
Web page address
https://osrc.tums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mojgan Karbakhsh Davari
Street address
Research and Technology Management Unit, Room 605, 6th Floor, Central Administrative Building, Tehran University of Medical Sciences, Qods Street, Keshavarz Boulevard, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
141765383761
Phone
+98 21 8163 3698
Fax
+98 21 8895 3003
Email
vcr@tums.ac.ir
Web page address
https://tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hasti Beykpour
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Energy and Architecture
Street address
No. 29,Shabnam 2 St, West Baghistan Blvd , Karaj
City
Karaj
Province
Alborz
Postal code
3194685344
Phone
+98 26 3434 9684
Email
Hasti.Beyk@edu.ikiu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Arezu Najafi
Position
Assistant Professor of Occupational Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Occupational Medicine
Street address
Yalda Clinic Building, No. 135, Keshavarz Boulevard (between Jamalzadeh St. and Gharib St.), Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417613151
Phone
+98 21 5546 0184
Email
najafeeaz.inbox@gmail.com
Web page address
https://cv.tums.ac.ir/cv/Arezu_Najafi

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hasti Beykpour
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Energy and Architecture
Street address
No. 29,Shabnam 2 St, West Baghistan Blvd , Karaj
City
Karaj
Province
Alborz
Postal code
3194685344
Phone
+98 26 3434 9684
Email
Hasti.Beyk@edu.ikiu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the data is potentially shareable after people are unidentifiable and is available to the public in the form of reports and articles
When the data will become available and for how long
Access to the data will begin immediately after the article is published
To whom data/document is available
All researchers from academic and scientific institutions and people in the field of industry can access it if they wish.
Under which criteria data/document could be used
A clear request for information and an attachment of an organizational certificate for the application.
From where data/document is obtainable
To access the information, you can refer to the project researcher, Ms. Hasti Beykpour with Hasti.Beyk@edu.ikiu.ac.ir email and 09025916667 mobile number, or the project executor, Dr. Arezoo Najafi, with najafeeaz.inbox@gmail.com email and 09173737580 mobile number
What processes are involved for a request to access data/document
Request for a certificate of approval of research from the organization or organization of study and research of origin Preparation of the Request Text Attach the certificate to the text and email to one of the two e-mail addresses. Check out the process
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