InsomniainsomniaNCT06776276
A Prospective Study: Tai-chi and Post-COVID Insomnia
A study testing Tai Chi exercises in people with Insomnia and COVID - 19, run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this study is to see if Tai-Chi exercises (a type of Chinese martial arts) can help people suffering from insomnia after COVID-19 when added with cognitive-behavioral therapy (CBT) and drugs compared to CBT and drugs alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Insomnia, COVID - 19
- What is being tested?
- Tai Chi exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Sep 2020to 25 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COVID-19 infections confirmed by PCR (polymerase chain reaction)
- Over the age of 18 years
Who cannot join
- Below the age of 18 years
- Severely ill patients
- Patients with chronic respiratory complications
- Individuals with pre-existing and ongoing depression or anxiety
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Adding Tai-chi Training to Pharmacotherapy in Post Covid Insomnia: a Prospective Study.
The goal of this study is to see if Tai-Chi exercises (a type of Chinese martial arts) can help people suffering from insomnia after COVID-19 when added with cognitive-behavioral therapy (CBT) and drugs compared to CBT and drugs alone. All participants will receive education on sleep hygiene practices, and the principles of cognitive behavioral therapy (CBT). If these approaches were insufficient, they will be given sleep aids, primarily Z-drugs.
All study subjects engaged in a simple Tai Chi training program for two weeks. The Tai Chi training consisted of a series of gentle physical exercises that incorporated elements of meditation, body awareness, imagery, and abdominal breathing.
A professional instructor conducted two training sessions for both patients and controls, ensuring that participants could perform the exercises independently at home during the last hour before sleep. Each session lasted twenty minutes, to be done daily. Participants were given a checklist documenting their sleep and exercise diary to confirm adherence for at least five days each week. After the two-week period, all participants are reassessed using the Insomnia severity index.
- Conditions
- Insomnia, COVID - 19
- Being tested
- Tai Chi exercises
- Keywords
- Insomnia, COVID-19, Tai Chi exercises, Insomnia severity index
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi exercisesBehavioural
Tai-chi (TC) is a kind of CAM Qigong exercises, is a type of classic Chinese martial arts. It entails deliberate, slow-motion physical movements that are done alongside inward concentration, awareness of breathing, and the inherent power or energy in the body. It promotes general purposes of health and spirituality. It is generally accessible and offered to older people in public places.
| Study group | Role | What they receive |
|---|---|---|
| Post-COVID Insomnia | Active comparator | Not described Receives: Behavioral: Tai Chi exercises |
| non-COVID-19-related insomnia | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index
The ISI measures the frequency of various insomnia symptoms, including prolonged sleep latency, difficulty maintain sleep, early awakening, satisfaction with sleep, interference with the daily activities, if it is noticed by others and if it is causing distress. Each of the seven items is rated on a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), resulting in a total score that can range from 0 to 28.
Measured: from enrollment to the end of treatment at 2 weeks follow up timestamp
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2025
- Study start20 Sep 2020
- Primary completion30 Dec 2023
- Study completion25 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06776276
- Sponsor's protocol ID
- 0305339
- Other IDs
- no funding
- Acronym
- insomnia
- Status last verified
- Sep 2020
- First submitted
- 11 Jan 2025
- Last updated
- 15 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Osypiuk K, Thompson E, Wayne PM. Can Tai Chi and Qigong Postures Shape Our Mood? Toward an Embodied Cognition Framework for Mind-Body Research. Front Hum Neurosci. 2018 May 1;12:174. doi: 10.3389/fnhum.2018.00174. eCollection 2018.
PubMed 29765313Chan SH, Ng SM, Yu CH, Chan CM, Wang SM, Chan WC. The effects of an integrated mindfulness-based tai chi chuan programme on sleep disturbance among community-dwelling elderly people: protocol for a randomized controlled trial. Trials. 2022 Sep 24;23(1):808. doi: 10.1186/s13063-022-06737-4.
PubMed 36153623Tong Y, Chai L, Lei S, Liu M, Yang L. Effects of Tai Chi on Self-Efficacy: A Systematic Review. Evid Based Complement Alternat Med. 2018 Aug 15;2018:1701372. doi: 10.1155/2018/1701372. eCollection 2018.
PubMed 30186352
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Adding Tai-chi Training to Pharmacotherapy in Post Covid Insomnia: a Prospective Study.
- ClinicalTrials.gov ID
- NCT06776276
- Acronym / sponsor ID
- insomnia / 0305339
- Conditions
- Insomnia, COVID - 19
- Keywords
- Insomnia, COVID-19, Tai Chi exercises, Insomnia severity index
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 337 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 25 Jan 2024 (actual)
- First posted
- 15 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to see if Tai-Chi exercises (a type of Chinese martial arts) can help people suffering from insomnia after COVID-19 when added with cognitive-behavioral therapy (CBT) and drugs compared to CBT and drugs alone. All participants will receive education on sleep hygiene practices, and the principles of cognitive behavioral therapy (CBT). If these approaches were insufficient, they will be given sleep aids, primarily Z-drugs.
All study subjects engaged in a simple Tai Chi training program for two weeks. The Tai Chi training consisted of a series of gentle physical exercises that incorporated elements of meditation, body awareness, imagery, and abdominal breathing.
A professional instructor conducted two training sessions for both patients and controls, ensuring that participants could perform the exercises independently at home during the last hour before sleep. Each session lasted twenty minutes, to be done daily. Participants were given a checklist documenting their sleep and exercise diary to confirm adherence for at least five days each week. After the two-week period, all participants are reassessed using the Insomnia severity index.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Post-COVID Insomnia | Active comparator | Behavioral: Tai Chi exercises |
| non-COVID-19-related insomnia | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- COVID-19 infections confirmed by PCR (polymerase chain reaction)
- Over the age of 18 years
Key exclusion criteria (4 listed)
- Below the age of 18 years
- Severely ill patients
- Patients with chronic respiratory complications
- Individuals with pre-existing and ongoing depression or anxiety
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi exercisesTai-chi (TC) is a kind of CAM Qigong exercises, is a type of classic Chinese martial arts. It entails deliberate, slow-motion physical movements that are done alongside inward concentration, awareness of breathing, and the inherent power or energy in the body. It promotes general purposes of health and spirituality. It is generally accessible and offered to older people in public places. | Behavioural | Post-COVID Insomnia |
Primary outcome
Insomnia Severity Index
Time frame: from enrollment to the end of treatment at 2 weeks follow up timestamp
The ISI measures the frequency of various insomnia symptoms, including prolonged sleep latency, difficulty maintain sleep, early awakening, satisfaction with sleep, interference with the daily activities, if it is noticed by others and if it is causing distress. Each of the seven items is rated on a 5-point Likert scale, ranging from 0 (no problem) to 4 (very severe problem), resulting in a total score that can range from 0 to 28.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2025.
- Background: PubMed 29765313Osypiuk K, Thompson E, Wayne PM. Can Tai Chi and Qigong Postures Shape Our Mood? Toward an Embodied Cognition Framework for Mind-Body Research. Front Hum Neurosci. 2018 May 1;12:174. doi: 10.3389/fnhum.2018.00174. eCollection 2018.
- Background: PubMed 36153623Chan SH, Ng SM, Yu CH, Chan CM, Wang SM, Chan WC. The effects of an integrated mindfulness-based tai chi chuan programme on sleep disturbance among community-dwelling elderly people: protocol for a randomized controlled trial. Trials. 2022 Sep 24;23(1):808. doi: 10.1186/s13063-022-06737-4.
- Background: PubMed 30186352Tong Y, Chai L, Lei S, Liu M, Yang L. Effects of Tai Chi on Self-Efficacy: A Systematic Review. Evid Based Complement Alternat Med. 2018 Aug 15;2018:1701372. doi: 10.1155/2018/1701372. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi exercises in people with Insomnia and COVID - 19, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (time frame: from enrollment to the end of treatment at 2 weeks follow up timestamp). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06776276, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2025.