Trial Outcomes & Findings for Study of Mattress Type in Fibromyalgia (NCT NCT01108718)

Results Overview

Study patients were asked to rate each test mattress after 2 months of use, based on their quality of sleep and severity of symptoms relating to fibromyalgia. The various stages of sleep were monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Change in severity of fibromyalgia symptoms were assessed by chi-squared and t-test.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

12 participants

Primary outcome timeframe

6 months

Results posted on

2017-03-10

Participant Flow

Patients from Principal Investigator's clinical practice at Beth Israel Medical Center in New York who fulfilled the 1990 case definition for fibromyalgia.

Subjects who displayed the existence of a previously undiagnosed sleep disorder were excluded from study participation.

Participant milestones

Participant milestones
Measure	Subjects Who Received the Tempur-Pedic Mattress First Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first, then the Control Mattress.	Subjects Who Received the Control Mattress First Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic mattress.
Received First Intervention (2 Months) STARTED	5	7
Received First Intervention (2 Months) COMPLETED	5	7
Received First Intervention (2 Months) NOT COMPLETED	0	0
Received Second Intervention (2 Months) STARTED	5	7
Received Second Intervention (2 Months) COMPLETED	4	7
Received Second Intervention (2 Months) NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Subjects Who Received the Tempur-Pedic Mattress First Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first, then the Control Mattress.	Subjects Who Received the Control Mattress First Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic mattress.
Received Second Intervention (2 Months) Withdrawal by Subject	1	0

Baseline Characteristics

Study of Mattress Type in Fibromyalgia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Who Receive Tempur-Pedic Mattress First(2 Months) n=5 Participants Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.	Subjects Who Receive the Control Mattress First(2 Months) n=7 Participants Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.	Total n=12 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Following 2 months use of each test mattress, the study patients' sleep patterns and severity of fibromyalgia symptoms were assessed. At the end of the study, study patients were asked to rate each mattress in order of preference.

Study patients were asked to rate each test mattress after 2 months of use, based on their quality of sleep and severity of symptoms relating to fibromyalgia. The various stages of sleep were monitored via polysomnography(PSG) and scored to indicate the degree to which they reflect a normal sleep pattern. Change in severity of fibromyalgia symptoms were assessed by chi-squared and t-test.

Outcome measures

Outcome measures
Measure	All Participants n=11 Participants All subjects used a tempur-pedic mattress and control mattress to sleep on in a cross over design for a period of 2 months per mattress.
Mattress Preference of Fibromyalgia Patients Tempur-Pedic Mattress	45 percentage of study participants Interval 5.0 to 95.0
Mattress Preference of Fibromyalgia Patients Control Mattress	55 percentage of study participants
Mattress Preference of Fibromyalgia Patients No Preference	0 percentage of study participants

Adverse Events

Subjects Who Received Tempur-Pedic Mattress First

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Subjects Who Received the Control Mattress First

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Subjects Who Received Tempur-Pedic Mattress First n=5 participants at risk Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first.	Subjects Who Received the Control Mattress First n=7 participants at risk Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first.
Investigations Subject's own Mattress Discarded	20.0% 1/5 • Number of events 1	0.00% 0/7

Additional Information

Diana Vu

Beth Israel Medical Center

Phone: 212-844-6747

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place